Tox | Related Drugs | BioActivity |

Stem definition	Drug id	CAS RN
tyrosine kinase inhibitors	785	302962-49-8

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: dasatinib sprycel spyrcel BMS-354825 dasatinib hydrate	A pyrimidine and thiazole derived ANTINEOPLASTIC AGENT and PROTEIN KINASE INHIBITOR of BCR-ABL KINASE. It is used in the treatment of patients with CHRONIC MYELOID LEUKEMIA who are resistant or intolerant to IMATINIB. Molecular weight: 488.01 Formula: C22H26ClN7O2S CLOGP: 2.71 LIPINSKI: 0 HAC: 9 HDO: 3 TPSA: 106.51 ALOGS: -4.58 ROTB: 7 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

dasatinib
sprycel
spyrcel
BMS-354825
dasatinib hydrate

A pyrimidine and thiazole derived ANTINEOPLASTIC AGENT and PROTEIN KINASE INHIBITOR of BCR-ABL KINASE. It is used in the treatment of patients with CHRONIC MYELOID LEUKEMIA who are resistant or intolerant to IMATINIB.

Molecular weight: 488.01
Formula: C22H26ClN7O2S
CLOGP: 2.71
LIPINSKI: 0
HAC: 9
HDO: 3
TPSA: 106.51
ALOGS: -4.58
ROTB: 7

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
0.10	g	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	0.10 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	5.85 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	15 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Property	Description	Value	Unit	Confidence	Similarity
azlogd74	LogD at pH 7.4	3.333		Moderate	0.72
caco2-efflux	Caco-2 efflux ratio (BA/AB)	34.119		Moderate	0.72
caco2-intrinsic-papp	Caco-2 intrinsic apparent permeability	10.162	10^-6 cm/s	Moderate	0.72
dh-clint	Dog hepatocyte intrinsic clearance	22.233	uL/min/10^6 cells	Moderate	0.72
dppb	Dog plasma protein binding (% unbound)	10.130	%	Moderate	0.72
fcs-ppb	Fetal calf serum protein binding (% unbound)	20.340	%	Moderate	0.72
herg	hERG pIC50	4.850	pIC50	Moderate	0.72
hh-clint	Human hepatocyte intrinsic clearance	19.634	uL/min/10^6 cells	Moderate	0.72
hlm-clint	Human liver microsomal intrinsic clearance	73.621	uL/min/mg protein	Moderate	0.72
hppb	Human plasma protein binding (% unbound)	5.180	%	Moderate	0.72
kinase-safety-class	ABL1,ABL2,ACVR1B,ACVR2A,ACVR2B,ACVRL1,AKT3,ALK,AURKA,AURKB,AURKC,AXL,BLK,BMX,BRAF,BTK,CAMK2B,CAMK2D,CDK1,CDK19,CDK4,CDK5,CDK9,CSF1R,CSK,DDR1,DYRK1B,EGFR,EPHA2,EPHB1,EPHB3,EPHB4,ERBB2,ERBB4,FGFR1,FLT1,FLT3,FYN,GAK,GRK2,INSR,IRAK1,ITK,JAK1,JAK2,KDR,KIT,LCK,LYN,MAP3K1,MAP3K10,MAP3K11,MAP3K21,MAP4K1,MAP4K2,MAP4K3,MAP4K5,MAPK11,MAPK14,MAPK7,MAPK9,MARK4,MET,MTOR,NTRK1,NTRK2,PDGFRB,PDK2,PDK4,PIK3CD,PIK3CG,PRKCD,PRKDC,PTK6,RET,RIPK3,SIK2,SIK3,SRC,STK10,STK33,SYK,TEK,TGFBR1,TNIK,TTK,TYRO3,ULK1,ULK2,YES1	90
kinase-selectivity-class	ABL2,ACVR1B,ACVR2B,ACVRL1,ALK,AXL,BLK,BMX,BRAF,BTK,CAMK2D,CDK9,CSF1R,CSK,DDR1,EGFR,EPHA2,EPHB3,EPHB4,ERBB2,ERBB4,FGFR1,FLT1,FLT3,FYN,GAK,GRK2,JAK1,KDR,KIT,LCK,LYN,MAP3K21,MAP4K1,MAP4K3,MAPK11,MAPK14,MAPK7,MET,MTOR,NTRK1,PAK4,PDGFRB,PDK4,PIK3CD,PRKCD,RET,RIPK3,SIK2,SIK3,SRC,SYK,TGFBR1,TYRO3,YES1	55
mdck-mdr1-bcrp-efflux	MDCK-MDR1-BCRP efflux ratio	31.477		High	1
mdck-mdr1-efflux	MDCK-MDR1 efflux ratio	55.590		Moderate	0.72
mh-clint	Mouse hepatocyte intrinsic clearance	56.494		Moderate	0.72
mppb	Mouse plasma protein binding (% unbound)	5.910		Moderate	0.72
nih-mdck-mdr1-efflux	NIH MDCK-MDR1 efflux ratio	33.574		Moderate	0.72
pfas-class	PFAS structural alert (1 = True, 0 = False)	0
pld-class	Phospholipidosis risk class (1 = positive, 0 = negative)	1		High	1
pppb	Pig plasma protein binding (% unbound)	12.960	%	Moderate	0.72
rat-kpuu-brain	Rat brain Kpuu	0.009	%	High	1
rh-clint	Rat hepatocyte intrinsic clearance	37.325	uL/min/10^6 cells	Moderate	0.72
rh-fuinc	Rat hepatocyte fraction unbound in incubation	34.310	%	Moderate	0.72
rppb	Rat plasma protein binding (% unbound)	7.160	%	Moderate	0.72
solubility-dd	Solubility at pH 7.4 in DMSO	7.834	uM	Moderate	0.72

Approvals:

Date	Agency	Company	Orphan
June 28, 2006	FDA	BRISTOL MYERS SQUIBB
Nov. 20, 2006	EMA	BRISTOL-MYERS SQUIBB PHARMA EEIG

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Pleural effusion	1811.52	19.04	801	25440	111190	90491016
Drug resistance	424.49	19.04	197	26044	30252	90571954
Pulmonary oedema	393.13	19.04	237	26004	61843	90540363
Cytogenetic analysis abnormal	380.59	19.04	82	26159	928	90601278
Hospitalisation	376.08	19.04	305	25936	127795	90474411
Adverse event	349.78	19.04	282	25959	117136	90485070
Philadelphia chromosome positive	333.49	19.04	65	26176	425	90601781
Chylothorax	308.27	19.04	60	26181	389	90601817
Acute lymphocytic leukaemia recurrent	295.18	19.04	81	26160	2640	90599566
Pericardial effusion	252.30	19.04	148	26093	36685	90565521
Malignant neoplasm progression	235.31	19.04	216	26025	106654	90495552
Blast crisis in myelogenous leukaemia	234.09	19.04	51	26190	610	90601596
Nausea	213.85	19.04	754	25487	1109562	89492644
Death	198.14	19.04	419	25822	456132	90146074
Fatigue	193.88	19.04	750	25491	1153273	89448933
Diarrhoea	184.95	19.04	643	25598	938547	89663659
Bone pain	180.41	19.04	147	26094	61836	90540370
Exposure via body fluid	170.82	19.04	39	26202	585	90601621
Emergency care examination	164.07	19.04	30	26211	131	90602075
Fluid retention	163.35	19.04	162	26079	87929	90514277
Headache	158.77	19.04	578	25663	862168	89740038
Prescribed underdose	148.49	19.04	143	26098	74876	90527330
Rash	132.70	19.04	517	25724	795583	89806623
Cytopenia	121.78	19.04	71	26170	17378	90584828
Haematotoxicity	120.50	19.04	63	26178	12472	90589734
Thrombocytopenia	114.94	19.04	212	26029	208513	90393693
Infusion related reaction	103.31	19.04	4	26237	416776	90185430
Chronic myeloid leukaemia recurrent	99.71	19.04	22	26219	280	90601926
Enterocolitis haemorrhagic	97.37	19.04	31	26210	1701	90600505
Myalgia	96.54	19.04	178	26063	174947	90427259
Pulmonary arterial hypertension	88.82	19.04	68	26173	26119	90576087
Systemic lupus erythematosus	87.92	19.04	4	26237	361892	90240314
Chronic myeloid leukaemia transformation	85.58	19.04	17	26224	124	90602082
Pancytopenia	84.31	19.04	136	26105	120127	90482079
Acne	81.62	19.04	67	26174	28440	90573766
Blast cell crisis	81.04	19.04	15	26226	71	90602135
Glossodynia	80.02	19.04	3	26238	321776	90280430
Chronic myeloid leukaemia	73.36	19.04	28	26213	2636	90599570
Pulmonary hypertension	72.90	19.04	75	26166	42448	90559758
Arthropathy	72.61	19.04	10	26231	366232	90235974
Anaemia	71.87	19.04	245	25996	352557	90249649
Leukaemia recurrent	69.24	19.04	23	26218	1444	90600762
Platelet count decreased	67.76	19.04	133	26108	136836	90465370
Joint swelling	62.48	19.04	34	26207	503266	90098940
Product dose omission issue	62.42	19.04	206	26035	291481	90310725
Therapeutic product effect decreased	61.59	19.04	5	26236	277566	90324640
Neutropenia	59.42	19.04	171	26070	224733	90377473
Large granular lymphocytosis	57.43	19.04	14	26227	282	90601924
Exposure during pregnancy	56.71	19.04	3	26238	238407	90363799
Condition aggravated	56.01	19.04	54	26187	595491	90006715
Enterococcal bacteraemia	54.71	19.04	21	26220	2007	90600199
Psoriatic arthropathy	53.91	19.04	3	26238	228332	90373874
Acute graft versus host disease	51.18	19.04	27	26214	5441	90596765
Fall	50.99	19.04	39	26202	481771	90120435
Bone marrow transplant	50.86	19.04	16	26225	844	90601362
Pericarditis	49.85	19.04	9	26232	270142	90332064
Helicobacter infection	47.88	19.04	5	26236	226845	90375361
Cytomegalovirus colitis	47.43	19.04	22	26219	3364	90598842
Impaired healing	47.33	19.04	6	26235	234193	90368013
Discomfort	46.78	19.04	11	26230	274324	90327882
Injury	45.36	19.04	3	26238	197346	90404860
Gene mutation identification test positive	44.31	19.04	10	26231	142	90602064
Type 2 diabetes mellitus	44.15	19.04	4	26237	203240	90398966
Polymerase chain reaction positive	43.13	19.04	10	26231	161	90602045
Therapeutic response delayed	42.82	19.04	14	26227	836	90601370
Splenomegaly	42.60	19.04	33	26208	12891	90589315
Lymphoid tissue hyperplasia	40.86	19.04	10	26231	205	90602001
Lipase increased	40.21	19.04	30	26211	11081	90591125
Fibromyalgia	39.99	19.04	6	26235	206263	90395943
Musculoskeletal stiffness	39.83	19.04	18	26223	296514	90305692
Drug intolerance	39.60	19.04	243	25998	447348	90154858
Folliculitis	39.49	19.04	6	26235	204347	90397859
Dyspnoea	39.17	19.04	408	25833	880547	89721659
Irritable bowel syndrome	38.07	19.04	7	26234	207441	90394765
Aspiration pleural cavity	37.87	19.04	13	26228	903	90601303
Osteoarthritis	37.25	19.04	6	26235	195724	90406482
Hepatic enzyme increased	37.13	19.04	30	26211	360706	90241500
Gene mutation	36.72	19.04	16	26225	2114	90600092
Skin disorder	36.54	19.04	49	26192	36657	90565549
Full blood count decreased	36.47	19.04	44	26197	29645	90572561
Graft versus host disease	36.39	19.04	25	26216	8119	90594087
Nephrotic syndrome	36.32	19.04	24	26217	7315	90594891
Drug hypersensitivity	35.99	19.04	49	26192	463560	90138646
Graft versus host disease in eye	35.29	19.04	8	26233	116	90602090
Central nervous system leukaemia	34.45	19.04	9	26232	242	90601964
Blood cholesterol increased	34.17	19.04	9	26232	208003	90394203
Strongyloidiasis	34.17	19.04	14	26227	1588	90600618
Pleurisy	33.61	19.04	25	26216	9192	90593014
C-reactive protein increased	33.55	19.04	6	26235	181383	90420823
Generalised oedema	33.36	19.04	34	26207	19019	90583187
Wheezing	32.68	19.04	14	26227	238066	90364140
Ill-defined disorder	32.34	19.04	7	26234	184884	90417322
Acute lymphocytic leukaemia	32.28	19.04	16	26225	2832	90599374
Constipation	31.93	19.04	163	26078	280232	90321974
Primary effusion lymphoma	31.36	19.04	5	26236	7	90602199
Sinusitis	31.18	19.04	32	26209	343056	90259150
Therapy cessation	30.92	19.04	45	26196	36316	90565890
Stem cell transplant	30.18	19.04	14	26227	2140	90600066
Philadelphia positive chronic myeloid leukaemia	30.18	19.04	6	26235	44	90602162
Confusional state	28.79	19.04	42	26199	386163	90216043
Skin toxicity	28.40	19.04	20	26221	6759	90595447
Liver injury	26.86	19.04	8	26233	170559	90431647
Chronic graft versus host disease	26.67	19.04	16	26225	4123	90598083
Gastrointestinal toxicity	26.57	19.04	22	26219	9445	90592761
Alopecia	26.19	19.04	238	26003	494833	90107373
Periorbital oedema	26.05	19.04	19	26222	6780	90595426
Hepatitis chronic active	26.03	19.04	6	26235	94	90602112
Colitis	25.45	19.04	60	26181	69882	90532324
Blister	25.25	19.04	22	26219	254976	90347230
Asthma	25.08	19.04	20	26221	242140	90360066
Febrile neutropenia	24.67	19.04	101	26140	158248	90443958
Subdural haematoma	24.35	19.04	27	26214	16618	90585588
Gastrointestinal haemorrhage	24.16	19.04	69	26172	90179	90512027
Capillary leak syndrome	24.03	19.04	13	26228	2754	90599452
Tessellated fundus	23.95	19.04	5	26236	48	90602158
Sleep disorder	23.64	19.04	14	26227	198016	90404190
Neuropathy peripheral	23.46	19.04	90	26151	136880	90465326
Acquired gene mutation	23.33	19.04	10	26231	1269	90600937
General physical health deterioration	22.40	19.04	43	26198	355072	90247134
Hypersensitivity	22.31	19.04	63	26178	454614	90147592
Cardiac failure congestive	22.23	19.04	71	26170	98623	90503583
Cardiac disorder	22.02	19.04	50	26191	56822	90545384
Blood disorder	21.65	19.04	18	26223	7772	90594434
Systemic candida	21.63	19.04	15	26226	4944	90597262
Leukocytosis	21.63	19.04	35	26206	30955	90571251
Therapy interrupted	21.61	19.04	46	26195	50062	90552144
Vomiting	20.48	19.04	331	25910	787962	89814244
Cardiac failure	20.46	19.04	74	26167	109422	90492784
Lymphocytosis	20.39	19.04	12	26229	2985	90599221
White blood cell count decreased	20.31	19.04	99	26142	167010	90435196
Bone marrow disorder	20.26	19.04	12	26229	3020	90599186
Intermittent claudication	19.95	19.04	10	26231	1813	90600393
Cytomegalovirus enterocolitis	19.88	19.04	8	26233	866	90601340
Gait inability	19.48	19.04	9	26232	146447	90455759
Blast cell proliferation	19.36	19.04	3	26238	3	90602203
Demyelinating polyneuropathy	19.30	19.04	8	26233	934	90601272
Cerebrovascular stenosis	19.29	19.04	4	26237	37	90602169
Leukaemia	19.24	19.04	14	26227	4978	90597228
Hypergammaglobulinaemia benign monoclonal	19.11	19.04	8	26233	958	90601248

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Pleural effusion	2140.76	16.36	1072	24189	96094	42499980
Adverse event	550.07	16.36	272	24989	23368	42572706
Drug resistance	484.35	16.36	283	24978	33965	42562109
Philadelphia chromosome positive	463.46	16.36	101	25160	540	42595534
Hospitalisation	396.49	16.36	338	24923	73992	42522082
Drug intolerance	298.95	16.36	299	24962	80125	42515949
Chylothorax	295.66	16.36	79	25182	1095	42594979
Prescribed underdose	252.97	16.36	123	25138	10159	42585915
Cytogenetic analysis abnormal	242.65	16.36	62	25199	713	42595361
Pulmonary oedema	239.37	16.36	220	25041	53052	42543022
Malignant neoplasm progression	238.60	16.36	307	24954	108093	42487981
Blast crisis in myelogenous leukaemia	231.88	16.36	58	25203	608	42595466
Headache	223.81	16.36	459	24802	238910	42357164
Fatigue	221.82	16.36	661	24600	434980	42161094
Acute lymphocytic leukaemia recurrent	181.84	16.36	72	25189	3619	42592455
Fluid retention	174.85	16.36	147	25114	31472	42564602
Pericardial effusion	169.97	16.36	140	25121	29135	42566939
Pulmonary hypertension	143.72	16.36	116	25145	23453	42572621
Pulmonary arterial hypertension	102.78	16.36	68	25193	10119	42585955
Death	102.13	16.36	548	24713	470637	42125437
Acne	89.24	16.36	70	25191	13574	42582500
Rash	88.43	16.36	361	24900	276593	42319481
Chronic myeloid leukaemia recurrent	82.37	16.36	21	25240	239	42595835
Gene mutation	81.68	16.36	33	25228	1748	42594326
Large granular lymphocytosis	77.25	16.36	20	25241	243	42595831
Chronic myeloid leukaemia transformation	76.76	16.36	19	25242	190	42595884
Diarrhoea	75.26	16.36	498	24763	460351	42135723
Bone pain	71.32	16.36	79	25182	23713	42572361
Gene mutation identification test positive	70.20	16.36	18	25243	210	42595864
Hypotension	69.43	16.36	33	25228	257598	42338476
Emergency care examination	68.70	16.36	13	25248	28	42596046
Thrombocytopenia	65.40	16.36	254	25007	190025	42406049
Chronic myeloid leukaemia	64.86	16.36	31	25230	2461	42593613
Enterocolitis haemorrhagic	63.40	16.36	24	25237	1067	42595007
Philadelphia positive chronic myeloid leukaemia	61.72	16.36	15	25246	138	42595936
Loss of therapeutic response	59.47	16.36	24	25237	1267	42594807
Lymphoid tissue hyperplasia	58.36	16.36	13	25248	78	42595996
Acquired gene mutation	58.06	16.36	25	25236	1555	42594519
Oedema	57.11	16.36	107	25154	51894	42544180
Central nervous system neoplasm	56.88	16.36	13	25248	89	42595985
Leukaemia recurrent	50.85	16.36	24	25237	1852	42594222
Blast cell proliferation	46.98	16.36	8	25253	6	42596068
Treatment failure	46.73	16.36	110	25151	62514	42533560
Minimal residual disease	44.73	16.36	16	25245	605	42595469
Condition aggravated	43.97	16.36	54	25207	260700	42335374
Aspiration pleural cavity	42.41	16.36	17	25244	882	42595192
Myalgia	39.47	16.36	136	25125	95944	42500130
Cytopenia	39.06	16.36	50	25211	17447	42578627
Cytomegalovirus colitis	38.76	16.36	26	25235	3955	42592119
Nausea	38.42	16.36	381	24880	396418	42199656
Bone marrow transplant	37.55	16.36	17	25244	1192	42594882
Drug ineffective	37.37	16.36	551	24710	629646	41966428
Bradycardia	36.55	16.36	4	25257	85480	42510594
Fall	35.04	16.36	53	25208	234467	42361607
Acute kidney injury	34.95	16.36	107	25154	367230	42228844
Blast cell crisis	34.49	16.36	9	25252	113	42595961
Loss of CAR T-cell persistence	33.77	16.36	7	25254	28	42596046
Therapy cessation	33.01	16.36	50	25211	20400	42575674
Skin disorder	32.56	16.36	45	25216	16899	42579175
Pleurisy	32.15	16.36	26	25235	5264	42590810
Toxicity to various agents	30.32	16.36	56	25205	229080	42366994
Natural killer cell count increased	29.81	16.36	5	25256	3	42596071
Platelet count decreased	29.62	16.36	161	25100	138420	42457654
Bone marrow disorder	29.58	16.36	17	25244	1969	42594105
Gastrointestinal toxicity	29.49	16.36	22	25239	3957	42592117
Product dose omission issue	28.83	16.36	173	25088	154192	42441882
Myopathy toxic	28.14	16.36	12	25249	729	42595345
Intentional product use issue	28.03	16.36	100	25161	71733	42524341
Remission not achieved	27.43	16.36	8	25253	155	42595919
Therapy change	26.75	16.36	21	25240	4074	42592000
Primary effusion lymphoma	26.39	16.36	6	25255	40	42596034
Bone marrow oedema	26.19	16.36	12	25249	865	42595209
Chronic myeloid leukaemia (in remission)	25.73	16.36	4	25257	0	42596074
Infusion related reaction	25.60	16.36	3	25258	60803	42535271
Gelatinous transformation of the bone marrow	25.49	16.36	5	25256	14	42596060
Haematotoxicity	25.48	16.36	32	25229	10953	42585121
Hyperkalaemia	25.44	16.36	8	25253	80450	42515624
Anterior interosseous syndrome	25.24	16.36	5	25256	15	42596059
Overdose	24.66	16.36	16	25245	105248	42490826
Therapeutic response decreased	24.39	16.36	62	25199	36950	42559124
Clonal evolution	24.38	16.36	7	25254	128	42595946
Hepatotoxicity	24.22	16.36	49	25212	25118	42570956
Right ventricular dysfunction	23.53	16.36	13	25248	1396	42594678
Bone marrow failure	23.45	16.36	57	25204	33036	42563038
Drug clearance decreased	23.09	16.36	15	25246	2163	42593911
Confusional state	23.02	16.36	40	25221	167557	42428517
Subdural hygroma	22.90	16.36	9	25252	443	42595631
Dyspnoea	22.68	16.36	378	24883	442243	42153831
Leukaemic infiltration extramedullary	22.36	16.36	7	25254	174	42595900
Neoplasm recurrence	22.32	16.36	16	25245	2708	42593366
Myeloid leukaemia	22.23	16.36	9	25252	479	42595595
Hyperplasia	22.09	16.36	10	25251	701	42595373
Asthma	21.95	16.36	5	25256	62309	42533765
Inappropriate schedule of product administration	21.89	16.36	15	25246	95887	42500187
Exercise tolerance decreased	21.45	16.36	22	25239	6044	42590030
Chromosome analysis abnormal	21.40	16.36	7	25254	201	42595873
Oxygen saturation decreased	21.23	16.36	6	25255	64681	42531393
Tremor	21.03	16.36	16	25245	96913	42499161
Second primary malignancy	20.80	16.36	27	25234	9548	42586526
Eyelid oedema	20.77	16.36	21	25240	5674	42590400
Central nervous system leukaemia	20.53	16.36	8	25253	385	42595689
Cardiac arrest	20.17	16.36	21	25240	109299	42486775
Leukocytosis	19.81	16.36	50	25211	29658	42566416
Syncope	19.61	16.36	18	25243	99388	42496686
Drug hypersensitivity	19.60	16.36	18	25243	99371	42496703
Acute lymphocytic leukaemia refractory	19.56	16.36	6	25255	139	42595935
Hallucination	19.50	16.36	5	25256	57502	42538572
Polymerase chain reaction positive	19.40	16.36	6	25255	143	42595931
Subclavian artery stenosis	19.00	16.36	5	25256	65	42596009
Hyphaema	18.87	16.36	9	25252	711	42595363
Bone neoplasm	18.87	16.36	7	25254	294	42595780
Graft versus host disease	18.62	16.36	30	25231	12895	42583179
Rectosigmoid cancer	17.91	16.36	6	25255	186	42595888
B-cell small lymphocytic lymphoma	17.81	16.36	6	25255	189	42595885
Allogenic bone marrow transplantation therapy	17.55	16.36	4	25257	27	42596047
Cerebellar syndrome	17.28	16.36	14	25247	2841	42593233
Lactic acidosis	17.27	16.36	3	25258	45258	42550816
Mutagenic effect	17.22	16.36	3	25258	3	42596071
Pancytopenia	17.13	16.36	124	25137	117619	42478455
Hyponatraemia	17.07	16.36	21	25240	101441	42494633
Peripheral artery stenosis	16.90	16.36	9	25252	898	42595176
Loss of consciousness	16.75	16.36	18	25243	92336	42503738
Cardio-respiratory arrest	16.55	16.36	7	25254	58629	42537445
Intentional overdose	16.47	16.36	5	25256	51451	42544623

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Pleural effusion	3383.76	15.84	1533	39473	176176	110372117
Philadelphia chromosome positive	669.92	15.84	134	40872	766	110547527
Chylothorax	659.53	15.84	138	40868	1018	110547275
Drug resistance	652.89	15.84	348	40658	56026	110492267
Hospitalisation	540.91	15.84	437	40569	142056	110406237
Pulmonary oedema	528.95	15.84	375	40631	100284	110448009
Blast crisis in myelogenous leukaemia	382.17	15.84	86	40920	922	110547371
Pericardial effusion	381.14	15.84	247	40759	56970	110491323
Malignant neoplasm progression	363.88	15.84	383	40623	174184	110374109
Adverse event	359.27	15.84	308	40698	108501	110439792
Acute lymphocytic leukaemia recurrent	349.15	15.84	116	40890	5671	110542622
Cytogenetic analysis abnormal	346.89	15.84	83	40923	1186	110547107
Fatigue	326.34	15.84	1088	39918	1214870	109333423
Death	281.66	15.84	724	40282	698145	109850148
Fluid retention	263.58	15.84	243	40763	94064	110454229
Headache	250.68	15.84	806	40200	881571	109666722
Emergency care examination	209.54	15.84	41	40965	205	110548088
Diarrhoea	194.49	15.84	885	40121	1138620	109409673
Pulmonary arterial hypertension	184.06	15.84	127	40879	32441	110515852
Bone pain	182.26	15.84	168	40838	64965	110483328
Rash	176.76	15.84	685	40321	820279	109728014
Thrombocytopenia	166.15	15.84	386	40620	348499	110199794
Prescribed underdose	164.94	15.84	159	40847	65015	110483278
Pulmonary hypertension	163.44	15.84	147	40859	55073	110493220
Chronic myeloid leukaemia transformation	152.55	15.84	33	40973	290	110548003
Enterocolitis haemorrhagic	152.31	15.84	51	40955	2553	110545740
Acne	151.20	15.84	114	40892	33406	110514887
Large granular lymphocytosis	141.81	15.84	34	40972	490	110547803
Nausea	132.23	15.84	845	40161	1234845	109313448
Infusion related reaction	116.60	15.84	6	41000	381156	110167137
Gene mutation	113.23	15.84	44	40962	3385	110544908
Chronic myeloid leukaemia	107.20	15.84	45	40961	4228	110544065
Chronic myeloid leukaemia recurrent	103.53	15.84	25	40981	372	110547921
Rheumatoid arthritis	97.40	15.84	3	41003	299610	110248683
Cytomegalovirus colitis	94.26	15.84	48	40958	7013	110541280
Philadelphia positive chronic myeloid leukaemia	92.03	15.84	20	40986	180	110548113
Cytopenia	90.73	15.84	81	40925	30035	110518258
Platelet count decreased	90.51	15.84	237	40769	230206	110318087
Haematotoxicity	89.13	15.84	69	40937	21013	110527280
Myalgia	84.57	15.84	226	40780	222155	110326138
Systemic lupus erythematosus	81.07	15.84	3	41003	254335	110293958
Condition aggravated	80.98	15.84	92	40914	734744	109813549
Fall	77.49	15.84	66	40940	603416	109944877
Acquired gene mutation	75.84	15.84	31	40975	2723	110545570
Drug intolerance	75.81	15.84	325	40681	406187	110142106
Arthropathy	75.48	15.84	9	40997	287513	110260780
Wound	73.92	15.84	3	41003	234434	110313859
Lower respiratory tract infection	73.77	15.84	4	41002	243102	110305191
Blast cell crisis	72.37	15.84	16	40990	157	110548136
Leukaemia recurrent	72.00	15.84	31	40975	3100	110545193
Pancytopenia	71.74	15.84	205	40801	209408	110338885
Gene mutation identification test positive	68.06	15.84	17	40989	293	110548000
Glossodynia	66.30	15.84	4	41002	222000	110326293
Therapy cessation	65.50	15.84	82	40924	44775	110503518
Therapeutic product effect decreased	63.26	15.84	8	40998	244308	110303985
Pleurisy	63.20	15.84	45	40961	12071	110536222
Psoriatic arthropathy	60.44	15.84	3	41003	196758	110351535
Aspiration pleural cavity	59.89	15.84	23	40983	1714	110546579
Hypotension	58.29	15.84	65	40941	523784	110024509
Bone marrow transplant	57.30	15.84	22	40984	1638	110546655
Full blood count decreased	57.29	15.84	65	40941	32034	110516259
Central nervous system leukaemia	57.19	15.84	17	40989	574	110547719
Mobility decreased	56.36	15.84	10	40996	237412	110310881
Musculoskeletal stiffness	56.10	15.84	17	40989	279805	110268488
Primary effusion lymphoma	55.89	15.84	11	40995	57	110548236
Joint swelling	54.91	15.84	50	40956	442795	110105498
Skin disorder	54.16	15.84	73	40933	42840	110505453
Lymphoid tissue hyperplasia	53.90	15.84	14	40992	284	110548009
Gastrointestinal toxicity	52.68	15.84	39	40967	11109	110537184
Osteoarthritis	52.45	15.84	4	41002	182619	110365674
Drug hypersensitivity	52.00	15.84	55	40951	454035	110094258
Anaemia	50.82	15.84	362	40644	546724	110001569
Blast cell proliferation	50.73	15.84	8	40998	6	110548287
Exposure during pregnancy	50.03	15.84	3	41003	167421	110380872
Oedema	49.68	15.84	181	40825	209795	110338498
Loss of therapeutic response	48.52	15.84	22	40984	2488	110545805
Fibromyalgia	48.36	15.84	4	41002	170905	110377388
Wheezing	46.84	15.84	18	40988	255212	110293081
Product dose omission issue	45.83	15.84	238	40768	321544	110226749
Type 2 diabetes mellitus	45.40	15.84	6	41000	177226	110371067
Impaired healing	45.16	15.84	9	40997	196708	110351585
Therapy change	45.07	15.84	34	40972	9963	110538330
Febrile neutropenia	44.91	15.84	234	40772	316533	110231760
Splenomegaly	44.38	15.84	50	40956	24448	110523845
Bone marrow failure	44.19	15.84	78	40928	57770	110490523
C-reactive protein increased	44.11	15.84	13	40993	217906	110330387
Injury	43.09	15.84	7	40999	177258	110371035
Helicobacter infection	42.43	15.84	8	40998	181869	110366424
Polymerase chain reaction positive	42.19	15.84	12	40994	346	110547947
Asthma	42.18	15.84	20	40986	250271	110298022
Clonal evolution	41.55	15.84	11	40995	241	110548052
Natural killer cell count increased	41.32	15.84	7	40999	12	110548281
Confusional state	41.18	15.84	69	40937	468611	110079682
Graft versus host disease	40.40	15.84	42	40964	18764	110529529
Discomfort	39.63	15.84	15	40991	214692	110333601
Enterococcal bacteraemia	39.20	15.84	23	40983	4438	110543855
Lipase increased	38.86	15.84	41	40965	18631	110529662
Mucosal inflammation	38.85	15.84	100	40906	96041	110452252
Generalised oedema	38.39	15.84	52	40954	30652	110517641
Neutropenia	38.37	15.84	254	40752	374366	110173927
Drug clearance decreased	38.20	15.84	22	40984	4100	110544193
Therapy interrupted	37.82	15.84	67	40939	49755	110498538
Folliculitis	37.80	15.84	8	40998	167645	110380648
Dyspnoea	37.57	15.84	597	40409	1106275	109442018
Leukocytosis	36.58	15.84	69	40937	53759	110494534
Chromosome analysis abnormal	35.61	15.84	10	40996	275	110548018
Chronic myeloid leukaemia (in remission)	35.52	15.84	6	41000	10	110548283
Nephrotic syndrome	35.45	15.84	34	40972	13797	110534496
Bone marrow disorder	35.09	15.84	21	40985	4202	110544091
Colitis	34.90	15.84	100	40906	102223	110446070
Irritable bowel syndrome	34.72	15.84	9	40997	164206	110384087
Drug ineffective	34.01	15.84	769	40237	1519771	109028522
Sleep disorder	33.27	15.84	16	40990	198628	110349665
Overdose	33.22	15.84	23	40983	233771	110314522
Peripheral artery stenosis	33.10	15.84	14	40992	1340	110546953
Psoriasis	32.99	15.84	6	41000	139987	110408306
Therapeutic response delayed	32.74	15.84	14	40992	1376	110546917
Intentional overdose	32.73	15.84	5	41001	132496	110415797
Oxygen saturation decreased	32.44	15.84	9	40997	156973	110391320
Blood cholesterol increased	32.32	15.84	14	40992	184771	110363522
Bone development abnormal	32.11	15.84	7	40999	64	110548229
Acute graft versus host disease	31.77	15.84	31	40975	12850	110535443
Loss of CAR T-cell persistence	31.75	15.84	6	41000	24	110548269
Malaise	31.57	15.84	135	40871	671684	109876609
White blood cell count increased	31.45	15.84	93	40913	96749	110451544
Acute lymphocytic leukaemia	31.43	15.84	22	40984	5743	110542550
Minimal residual disease	30.66	15.84	12	40994	941	110547352
Sinusitis	30.63	15.84	39	40967	296649	110251644
Inappropriate schedule of product administration	30.33	15.84	19	40987	203618	110344675
Skin toxicity	30.27	15.84	29	40977	11754	110536539
Periorbital oedema	29.88	15.84	27	40979	10165	110538128
Central nervous system neoplasm	29.85	15.84	8	40998	184	110548109
Product use in unapproved indication	29.12	15.84	78	40928	447299	110100994
Blister	28.96	15.84	25	40981	227351	110320942
Hepatic enzyme increased	28.39	15.84	47	40959	320845	110227448
Hypersensitivity	28.18	15.84	68	40938	403930	110144363
Acute graft versus host disease in intestine	27.26	15.84	20	40986	5619	110542674
Ill-defined disorder	27.25	15.84	12	40994	156841	110391452
Graft versus host disease in eye	26.86	15.84	9	40997	451	110547842
White blood cell count decreased	26.86	15.84	161	40845	229229	110319064
Intentional product misuse	26.76	15.84	8	40998	132896	110415397
Cardiac disorder	26.45	15.84	75	40931	76205	110472088
Obesity	26.40	15.84	5	41001	113346	110434947
Anterior interosseous syndrome	25.90	15.84	5	41001	23	110548270
Remission not achieved	25.67	15.84	9	40997	518	110547775
Pericarditis	25.66	15.84	26	40980	219088	110329205
Toxicity to various agents	25.46	15.84	92	40914	480463	110067830
Wound infection	25.35	15.84	3	41003	96462	110451831
Urticaria	25.26	15.84	50	40956	318807	110229486
Therapeutic response decreased	25.23	15.84	86	40920	96413	110451880
Strongyloidiasis	24.82	15.84	18	40988	4968	110543325
Intermittent claudication	24.67	15.84	16	40990	3685	110544608
Subdural hygroma	24.44	15.84	9	40997	597	110547696
Leukaemia	24.20	15.84	21	40985	7497	110540796
Lactic acidosis	24.11	15.84	3	41003	92808	110455485
Metabolic acidosis	24.10	15.84	4	41002	99740	110448553
Liver injury	23.86	15.84	13	40993	150400	110397893
Medication error	23.80	15.84	5	41001	105361	110442932
Syncope	23.75	15.84	24	40982	202512	110345781
Hypercholesterolaemia	23.44	15.84	3	41003	90834	110457459
Haemothorax	23.36	15.84	20	40986	7011	110541282
Somnolence	23.25	15.84	47	40959	297402	110250891
Eye swelling	23.25	15.84	43	40963	33005	110515288
Dry mouth	23.10	15.84	24	40982	199924	110348369
Systemic candida	22.74	15.84	23	40983	9951	110538342
Tessellated fundus	22.72	15.84	5	41001	48	110548245
Hepatotoxicity	22.63	15.84	63	40943	63337	110484956
Eyelid oedema	22.44	15.84	28	40978	15234	110533059
Hyperplasia	22.26	15.84	11	40995	1507	110546786
Osteoporosis	22.20	15.84	3	41003	87149	110461144
Stem cell transplant	22.08	15.84	16	40990	4411	110543882
Growth retardation	21.87	15.84	13	40993	2569	110545724
Arthritis	21.86	15.84	18	40988	167568	110380725
Lymphocytosis	21.34	15.84	17	40989	5394	110542899
Bone marrow oedema	21.31	15.84	12	40994	2144	110546149
Right ventricular dysfunction	21.26	15.84	14	40992	3309	110544984
Peripheral venous disease	21.18	15.84	3	41003	84114	110464179
Product administered to patient of inappropriate age	21.06	15.84	20	40986	8016	110540277
Transplant	21.00	15.84	10	40996	1264	110547029
Delirium	20.94	15.84	12	40994	135013	110413280
Myeloid leukaemia	20.94	15.84	9	40997	896	110547397
Blood pressure systolic increased	20.80	15.84	3	41003	82988	110465305
Cytomegalovirus enterocolitis	20.68	15.84	12	40994	2269	110546024
Myopathy toxic	20.63	15.84	10	40996	1315	110546978
Drug reaction with eosinophilia and systemic symptoms	20.50	15.84	3	41003	82092	110466201
Tremor	20.44	15.84	27	40979	202205	110346088
Peripheral arterial occlusive disease	20.43	15.84	21	40985	9259	110539034
Subdural haematoma	20.29	15.84	43	40963	36411	110511882
Second primary malignancy	20.20	15.84	29	40977	18039	110530254
Cytomegalovirus infection reactivation	19.87	15.84	29	40977	18304	110529989
Cardiac failure	19.65	15.84	128	40878	187498	110360795
Drug-induced liver injury	19.60	15.84	10	40996	120057	110428236
Gelatinous transformation of the bone marrow	19.55	15.84	4	41002	26	110548267
Blood disorder	19.46	15.84	21	40985	9789	110538504
Gait disturbance	19.25	15.84	47	40959	278161	110270132
Face oedema	19.23	15.84	40	40966	33429	110514864
Hyphaema	19.20	15.84	9	40997	1098	110547195
General physical health deterioration	19.01	15.84	87	40919	425208	110123085
Acute myeloid leukaemia	18.99	15.84	43	40963	38067	110510226
Graft versus host disease in skin	18.76	15.84	19	40987	8235	110540058
Constipation	18.73	15.84	209	40797	357577	110190716
Blast cell count increased	18.63	15.84	10	40996	1627	110546666
Hydrothorax	18.51	15.84	10	40996	1648	110546645
Blood pressure increased	18.39	15.84	43	40963	258330	110289963
Inflammation	18.33	15.84	27	40979	193211	110355082
Hepatitis chronic active	18.10	15.84	6	41000	291	110548002
Blood pressure fluctuation	18.08	15.84	3	41003	74821	110473472
Sciatica	17.82	15.84	6	41000	92393	110455900
Neoplasm malignant	17.51	15.84	41	40965	37102	110511191
Multiple-drug resistance	17.44	15.84	23	40983	13212	110535081
Allogenic bone marrow transplantation therapy	17.44	15.84	4	41002	47	110548246
Mutagenic effect	17.41	15.84	3	41003	6	110548287
Depressed level of consciousness	17.38	15.84	10	40996	112268	110436025
Gait inability	17.35	15.84	15	40991	136361	110411932
Loss of consciousness	17.13	15.84	29	40977	196277	110352016
Cerebellar syndrome	17.12	15.84	16	40990	6286	110542007
Leukaemic infiltration extramedullary	17.10	15.84	6	41000	346	110547947
Cardiac tamponade	17.03	15.84	21	40985	11286	110537007
Hyperhidrosis	16.96	15.84	27	40979	187271	110361022
Pneumonia fungal	16.96	15.84	24	40982	14730	110533563
Product quality issue	16.79	15.84	4	41002	77295	110470998
Severe invasive streptococcal infection	16.79	15.84	4	41002	56	110548237
Right ventricular enlargement	16.79	15.84	8	40998	1013	110547280
Tumour lysis syndrome	16.76	15.84	36	40970	30765	110517528
Cytomegalovirus infection	16.46	15.84	51	40955	54393	110493900
Sedation	16.39	15.84	3	41003	69680	110478613
Hypergammaglobulinaemia benign monoclonal	16.30	15.84	8	40998	1081	110547212
Pyrexia	16.28	15.84	442	40564	897823	109650470
Therapy non-responder	16.28	15.84	107	40899	157200	110391093
Fusarium infection	16.11	15.84	11	40995	2760	110545533
Ventricular enlargement	16.10	15.84	7	40999	717	110547576
Hyperkalaemia	16.02	15.84	16	40990	135780	110412513
Road traffic accident	16.02	15.84	10	40996	107388	110440905
Bacteraemia	16.00	15.84	43	40963	42347	110505946
Exercise tolerance decreased	15.95	15.84	21	40985	12046	110536247
Bone marrow necrosis	15.91	15.84	6	41000	425	110547868

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	L01EA02	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS PROTEIN KINASE INHIBITORS BCR-ABL tyrosine kinase inhibitors
MeSH PA	D000092004	Tyrosine Kinase Inhibitors
MeSH PA	D000970	Antineoplastic Agents
MeSH PA	D004791	Enzyme Inhibitors
MeSH PA	D047428	Protein Kinase Inhibitors
CHEBI has role	CHEBI:35610	antineoplastic agents
CHEBI has role	CHEBI:38637	tyrosine kinase inhibitors
CHEBI has role	CHEBI:149553	anticoronaviral drug

Related Drugs by ATC class:

L01EA BCR-ABL tyrosine kinase inhibitors 5 drugs

asciminib bosutinib imatinib nilotinib ponatinib

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Blastic phase chronic myeloid leukemia	indication	413656006
Chronic phase chronic myeloid leukemia	indication	413847001
Philadelphia chromosome-positive acute lymphoblastic leukemia	indication	425688002
Philadelphia Chromosome Positive Chronic Myelocytic Leukemia	indication
Chronic Myelocytic Leukemia Accelerated Phase	indication
Acute hemorrhage	contraindication	8573003
Myocardial infarction	contraindication	22298006	DOID:5844
Torsades de pointes	contraindication	31722008
Body fluid retention	contraindication	43498006
Chronic heart failure	contraindication	48447003
Gastrointestinal hemorrhage	contraindication	74474003
Left heart failure	contraindication	85232009
Prolonged QT interval	contraindication	111975006
Disease of liver	contraindication	235856003	DOID:409
Edema	contraindication	267038008
Anemia	contraindication	271737000	DOID:2355
Cerebral hemorrhage	contraindication	274100004
Pregnancy, function	contraindication	289908002
Thrombocytopenic disorder	contraindication	302215000	DOID:1588
Neutropenic disorder	contraindication	303011007	DOID:1227
Pericardial effusion	contraindication	373945007	DOID:118
Ascites	contraindication	389026000
Breastfeeding (mother)	contraindication	413712001
Congenital long QT syndrome	contraindication	442917000
Pleural Effusions	contraindication

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	8.56	acidic
pKa2	7.72	Basic
pKa3	4.89	Basic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
100MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	11202778	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH CHRONIC, ACCELERATED, OR MYELOID OR LYMPHOID BLAST PHASE PH+ CML WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY INCLUDING IMATINIB, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
100MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	11202778	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH PH+ ALL WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
100MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	11202778	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF NEWLY DIAGNOSED ADULTS WITH PH+ CML IN CHRONIC PHASE, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
100MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	11324745	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH CHRONIC, ACCELERATED, OR MYELOID OR LYMPHOID BLAST PHASE PH+ CML WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY INCLUDING IMATINIB, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
100MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	11324745	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH PH+ ALL WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
100MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	11324745	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF NEWLY DIAGNOSED ADULTS WITH PH+ CML IN CHRONIC PHASE, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
100MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12433891	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH CHRONIC, ACCELERATED, OR MYELOID OR LYMPHOID BLAST PHASE PH+ CML WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY INCLUDING IMATINIB, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
100MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12433891	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH CHRONIC, ACCELERATED, OR MYELOID OR LYMPHOID BLAST PHASE PH+ CML WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY INCLUDING IMATINIB, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
100MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12433891	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH PH+ ALL WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
100MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12433891	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH PH+ ALL WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
100MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12433891	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF NEWLY DIAGNOSED ADULTS WITH PH+ CML IN CHRONIC PHASE, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
100MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12433891	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF NEWLY DIAGNOSED ADULTS WITH PH+ CML IN CHRONIC PHASE, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
100MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12544376	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH CHRONIC, ACCELERATED, OR MYELOID OR LYMPHOID BLAST PHASE PH+ CML WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY INCLUDING IMATINIB, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
100MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12544376	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH CHRONIC, ACCELERATED, OR MYELOID OR LYMPHOID BLAST PHASE PH+ CML WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY INCLUDING IMATINIB, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
100MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12544376	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH PH+ ALL WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
100MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12544376	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH PH+ ALL WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
100MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12544376	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF NEWLY DIAGNOSED ADULTS WITH PH+ CML IN CHRONIC PHASE, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
100MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12544376	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF NEWLY DIAGNOSED ADULTS WITH PH+ CML IN CHRONIC PHASE, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
140MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	11202778	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH CHRONIC, ACCELERATED, OR MYELOID OR LYMPHOID BLAST PHASE PH+ CML WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY INCLUDING IMATINIB, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
140MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	11202778	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH PH+ ALL WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
140MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	11202778	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF NEWLY DIAGNOSED ADULTS WITH PH+ CML IN CHRONIC PHASE, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
140MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	11324745	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH CHRONIC, ACCELERATED, OR MYELOID OR LYMPHOID BLAST PHASE PH+ CML WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY INCLUDING IMATINIB, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
140MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	11324745	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH PH+ ALL WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
140MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	11324745	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF NEWLY DIAGNOSED ADULTS WITH PH+ CML IN CHRONIC PHASE, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
140MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12433891	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH CHRONIC, ACCELERATED, OR MYELOID OR LYMPHOID BLAST PHASE PH+ CML WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY INCLUDING IMATINIB, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
140MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12433891	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH CHRONIC, ACCELERATED, OR MYELOID OR LYMPHOID BLAST PHASE PH+ CML WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY INCLUDING IMATINIB, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
140MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12433891	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH PH+ ALL WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
140MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12433891	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH PH+ ALL WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
140MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12433891	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF NEWLY DIAGNOSED ADULTS WITH PH+ CML IN CHRONIC PHASE, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
140MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12433891	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF NEWLY DIAGNOSED ADULTS WITH PH+ CML IN CHRONIC PHASE, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
140MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12544376	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH CHRONIC, ACCELERATED, OR MYELOID OR LYMPHOID BLAST PHASE PH+ CML WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY INCLUDING IMATINIB, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
140MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12544376	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH CHRONIC, ACCELERATED, OR MYELOID OR LYMPHOID BLAST PHASE PH+ CML WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY INCLUDING IMATINIB, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
140MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12544376	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH PH+ ALL WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
140MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12544376	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH PH+ ALL WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
140MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12544376	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF NEWLY DIAGNOSED ADULTS WITH PH+ CML IN CHRONIC PHASE, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
140MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12544376	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF NEWLY DIAGNOSED ADULTS WITH PH+ CML IN CHRONIC PHASE, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
20MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	11202778	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH CHRONIC, ACCELERATED, OR MYELOID OR LYMPHOID BLAST PHASE PH+ CML WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY INCLUDING IMATINIB, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
20MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	11202778	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH PH+ ALL WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
20MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	11202778	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF NEWLY DIAGNOSED ADULTS WITH PH+ CML IN CHRONIC PHASE, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
20MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	11324745	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH CHRONIC, ACCELERATED, OR MYELOID OR LYMPHOID BLAST PHASE PH+ CML WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY INCLUDING IMATINIB, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
20MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	11324745	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH PH+ ALL WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
20MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	11324745	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF NEWLY DIAGNOSED ADULTS WITH PH+ CML IN CHRONIC PHASE, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
20MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12433891	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH CHRONIC, ACCELERATED, OR MYELOID OR LYMPHOID BLAST PHASE PH+ CML WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY INCLUDING IMATINIB, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
20MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12433891	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH CHRONIC, ACCELERATED, OR MYELOID OR LYMPHOID BLAST PHASE PH+ CML WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY INCLUDING IMATINIB, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
20MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12433891	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH PH+ ALL WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
20MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12433891	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH PH+ ALL WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
20MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12433891	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF NEWLY DIAGNOSED ADULTS WITH PH+ CML IN CHRONIC PHASE, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
20MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12433891	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF NEWLY DIAGNOSED ADULTS WITH PH+ CML IN CHRONIC PHASE, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
20MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12544376	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH CHRONIC, ACCELERATED, OR MYELOID OR LYMPHOID BLAST PHASE PH+ CML WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY INCLUDING IMATINIB, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
20MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12544376	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH CHRONIC, ACCELERATED, OR MYELOID OR LYMPHOID BLAST PHASE PH+ CML WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY INCLUDING IMATINIB, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
20MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12544376	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH PH+ ALL WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
20MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12544376	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH PH+ ALL WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
20MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12544376	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF NEWLY DIAGNOSED ADULTS WITH PH+ CML IN CHRONIC PHASE, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
20MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12544376	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF NEWLY DIAGNOSED ADULTS WITH PH+ CML IN CHRONIC PHASE, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
50MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	11202778	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH CHRONIC, ACCELERATED, OR MYELOID OR LYMPHOID BLAST PHASE PH+ CML WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY INCLUDING IMATINIB, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
50MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	11202778	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH PH+ ALL WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
50MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	11202778	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF NEWLY DIAGNOSED ADULTS WITH PH+ CML IN CHRONIC PHASE, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
50MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	11324745	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH CHRONIC, ACCELERATED, OR MYELOID OR LYMPHOID BLAST PHASE PH+ CML WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY INCLUDING IMATINIB, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
50MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	11324745	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH PH+ ALL WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
50MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	11324745	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF NEWLY DIAGNOSED ADULTS WITH PH+ CML IN CHRONIC PHASE, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
50MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12433891	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH CHRONIC, ACCELERATED, OR MYELOID OR LYMPHOID BLAST PHASE PH+ CML WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY INCLUDING IMATINIB, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
50MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12433891	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH CHRONIC, ACCELERATED, OR MYELOID OR LYMPHOID BLAST PHASE PH+ CML WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY INCLUDING IMATINIB, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
50MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12433891	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH PH+ ALL WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
50MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12433891	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH PH+ ALL WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
50MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12433891	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF NEWLY DIAGNOSED ADULTS WITH PH+ CML IN CHRONIC PHASE, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
50MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12433891	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF NEWLY DIAGNOSED ADULTS WITH PH+ CML IN CHRONIC PHASE, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
50MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12544376	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH CHRONIC, ACCELERATED, OR MYELOID OR LYMPHOID BLAST PHASE PH+ CML WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY INCLUDING IMATINIB, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
50MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12544376	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH CHRONIC, ACCELERATED, OR MYELOID OR LYMPHOID BLAST PHASE PH+ CML WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY INCLUDING IMATINIB, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
50MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12544376	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH PH+ ALL WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
50MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12544376	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH PH+ ALL WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
50MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12544376	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF NEWLY DIAGNOSED ADULTS WITH PH+ CML IN CHRONIC PHASE, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
50MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12544376	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF NEWLY DIAGNOSED ADULTS WITH PH+ CML IN CHRONIC PHASE, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
70MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	11202778	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH CHRONIC, ACCELERATED, OR MYELOID OR LYMPHOID BLAST PHASE PH+ CML WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY INCLUDING IMATINIB, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
70MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	11202778	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH PH+ ALL WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
70MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	11202778	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF NEWLY DIAGNOSED ADULTS WITH PH+ CML IN CHRONIC PHASE, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
70MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	11324745	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH CHRONIC, ACCELERATED, OR MYELOID OR LYMPHOID BLAST PHASE PH+ CML WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY INCLUDING IMATINIB, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
70MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	11324745	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH PH+ ALL WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
70MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	11324745	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF NEWLY DIAGNOSED ADULTS WITH PH+ CML IN CHRONIC PHASE, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
70MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12433891	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH CHRONIC, ACCELERATED, OR MYELOID OR LYMPHOID BLAST PHASE PH+ CML WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY INCLUDING IMATINIB, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
70MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12433891	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH CHRONIC, ACCELERATED, OR MYELOID OR LYMPHOID BLAST PHASE PH+ CML WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY INCLUDING IMATINIB, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
70MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12433891	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH PH+ ALL WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
70MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12433891	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH PH+ ALL WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
70MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12433891	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF NEWLY DIAGNOSED ADULTS WITH PH+ CML IN CHRONIC PHASE, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
70MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12433891	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF NEWLY DIAGNOSED ADULTS WITH PH+ CML IN CHRONIC PHASE, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
70MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12544376	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH CHRONIC, ACCELERATED, OR MYELOID OR LYMPHOID BLAST PHASE PH+ CML WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY INCLUDING IMATINIB, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
70MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12544376	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH CHRONIC, ACCELERATED, OR MYELOID OR LYMPHOID BLAST PHASE PH+ CML WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY INCLUDING IMATINIB, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
70MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12544376	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH PH+ ALL WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
70MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12544376	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH PH+ ALL WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
70MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12544376	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF NEWLY DIAGNOSED ADULTS WITH PH+ CML IN CHRONIC PHASE, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
70MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12544376	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF NEWLY DIAGNOSED ADULTS WITH PH+ CML IN CHRONIC PHASE, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
80MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	11202778	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH CHRONIC, ACCELERATED, OR MYELOID OR LYMPHOID BLAST PHASE PH+ CML WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY INCLUDING IMATINIB, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
80MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	11202778	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH PH+ ALL WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
80MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	11202778	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF NEWLY DIAGNOSED ADULTS WITH PH+ CML IN CHRONIC PHASE, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
80MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	11324745	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH CHRONIC, ACCELERATED, OR MYELOID OR LYMPHOID BLAST PHASE PH+ CML WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY INCLUDING IMATINIB, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
80MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	11324745	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH PH+ ALL WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
80MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	11324745	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF NEWLY DIAGNOSED ADULTS WITH PH+ CML IN CHRONIC PHASE, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
80MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12433891	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH CHRONIC, ACCELERATED, OR MYELOID OR LYMPHOID BLAST PHASE PH+ CML WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY INCLUDING IMATINIB, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
80MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12433891	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH CHRONIC, ACCELERATED, OR MYELOID OR LYMPHOID BLAST PHASE PH+ CML WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY INCLUDING IMATINIB, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
80MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12433891	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH PH+ ALL WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
80MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12433891	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH PH+ ALL WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
80MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12433891	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF NEWLY DIAGNOSED ADULTS WITH PH+ CML IN CHRONIC PHASE, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
80MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12433891	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF NEWLY DIAGNOSED ADULTS WITH PH+ CML IN CHRONIC PHASE, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
80MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12544376	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH CHRONIC, ACCELERATED, OR MYELOID OR LYMPHOID BLAST PHASE PH+ CML WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY INCLUDING IMATINIB, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
80MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12544376	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH CHRONIC, ACCELERATED, OR MYELOID OR LYMPHOID BLAST PHASE PH+ CML WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY INCLUDING IMATINIB, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
80MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12544376	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH PH+ ALL WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
80MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12544376	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF ADULTS WITH PH+ ALL WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT
80MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12544376	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF NEWLY DIAGNOSED ADULTS WITH PH+ CML IN CHRONIC PHASE, WHEN ADMINISTERED AT ELEVATED GASTRIC PH
80MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	12544376	Jan. 22, 2041	USE OF DASATINIB FOR TREATMENT OF NEWLY DIAGNOSED ADULTS WITH PH+ CML IN CHRONIC PHASE, WHEN COADMINISTERED WITH A GASTRIC ACID REDUCING AGENT

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
100MG	SPRYCEL	BRISTOL MYERS SQUIBB	N021986	May 30, 2008	RX	TABLET	ORAL	Dec. 21, 2025	INDICATED FOR THE TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) IN COMBINATION WITH CHEMOTHERAPY
140MG	SPRYCEL	BRISTOL MYERS SQUIBB	N021986	Oct. 28, 2010	RX	TABLET	ORAL	Dec. 21, 2025	INDICATED FOR THE TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) IN COMBINATION WITH CHEMOTHERAPY
20MG	SPRYCEL	BRISTOL MYERS SQUIBB	N021986	June 28, 2006	RX	TABLET	ORAL	Dec. 21, 2025	INDICATED FOR THE TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) IN COMBINATION WITH CHEMOTHERAPY
50MG	SPRYCEL	BRISTOL MYERS SQUIBB	N021986	June 28, 2006	RX	TABLET	ORAL	Dec. 21, 2025	INDICATED FOR THE TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) IN COMBINATION WITH CHEMOTHERAPY
70MG	SPRYCEL	BRISTOL MYERS SQUIBB	N021986	June 28, 2006	RX	TABLET	ORAL	Dec. 21, 2025	INDICATED FOR THE TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) IN COMBINATION WITH CHEMOTHERAPY
80MG	SPRYCEL	BRISTOL MYERS SQUIBB	N021986	Oct. 28, 2010	RX	TABLET	ORAL	Dec. 21, 2025	INDICATED FOR THE TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) IN COMBINATION WITH CHEMOTHERAPY
100MG	SPRYCEL	BRISTOL MYERS SQUIBB	N021986	May 30, 2008	RX	TABLET	ORAL	June 21, 2026	PEDIATRIC EXCLUSIVITY
140MG	SPRYCEL	BRISTOL MYERS SQUIBB	N021986	Oct. 28, 2010	RX	TABLET	ORAL	June 21, 2026	PEDIATRIC EXCLUSIVITY
20MG	SPRYCEL	BRISTOL MYERS SQUIBB	N021986	June 28, 2006	RX	TABLET	ORAL	June 21, 2026	PEDIATRIC EXCLUSIVITY
50MG	SPRYCEL	BRISTOL MYERS SQUIBB	N021986	June 28, 2006	RX	TABLET	ORAL	June 21, 2026	PEDIATRIC EXCLUSIVITY
70MG	SPRYCEL	BRISTOL MYERS SQUIBB	N021986	June 28, 2006	RX	TABLET	ORAL	June 21, 2026	PEDIATRIC EXCLUSIVITY
80MG	SPRYCEL	BRISTOL MYERS SQUIBB	N021986	Oct. 28, 2010	RX	TABLET	ORAL	June 21, 2026	PEDIATRIC EXCLUSIVITY
100MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	Dec. 5, 2026	INFORMATION ADDED TO THE CLINICAL PHARMACOLOGY SECTION TO INCLUDE RESULTS FROM A DRUG INTERACTION STUDY WITH GASTRIC ACID REDUCING AGENTS
140MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	Dec. 5, 2026	INFORMATION ADDED TO THE CLINICAL PHARMACOLOGY SECTION TO INCLUDE RESULTS FROM A DRUG INTERACTION STUDY WITH GASTRIC ACID REDUCING AGENTS
20MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	Dec. 5, 2026	INFORMATION ADDED TO THE CLINICAL PHARMACOLOGY SECTION TO INCLUDE RESULTS FROM A DRUG INTERACTION STUDY WITH GASTRIC ACID REDUCING AGENTS
50MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	Dec. 5, 2026	INFORMATION ADDED TO THE CLINICAL PHARMACOLOGY SECTION TO INCLUDE RESULTS FROM A DRUG INTERACTION STUDY WITH GASTRIC ACID REDUCING AGENTS
70MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	Dec. 5, 2026	INFORMATION ADDED TO THE CLINICAL PHARMACOLOGY SECTION TO INCLUDE RESULTS FROM A DRUG INTERACTION STUDY WITH GASTRIC ACID REDUCING AGENTS
80MG	PHYRAGO	HANDA THERAP	N216099	Dec. 5, 2023	RX	TABLET	ORAL	Dec. 5, 2026	INFORMATION ADDED TO THE CLINICAL PHARMACOLOGY SECTION TO INCLUDE RESULTS FROM A DRUG INTERACTION STUDY WITH GASTRIC ACID REDUCING AGENTS

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Tyrosine-protein kinase ABL1	Kinase	P00519	ABL1_HUMAN	INHIBITOR	IC50	9.60	IUPHAR	CHEMBL
Mast/stem cell growth factor receptor Kit	Kinase	P10721	KIT_HUMAN	INHIBITOR	Kd	9.24	CHEMBL	CHEMBL
Proto-oncogene tyrosine-protein kinase Src	Kinase	P12931	SRC_HUMAN	INHIBITOR	Kd	9.68	CHEMBL	CHEMBL
Tyrosine-protein kinase Lck	Kinase	P06239	LCK_HUMAN	INHIBITOR	Kd	9.70	CHEMBL	CHEMBL
Tyrosine-protein kinase Yes	Kinase	P07947	YES_HUMAN	INHIBITOR	Kd	9.52	CHEMBL	CHEMBL
Tyrosine-protein kinase Fyn	Kinase	P06241	FYN_HUMAN	INHIBITOR	Kd	9.10	CHEMBL	CHEMBL
Ephrin type-A receptor 2	Kinase	P29317	EPHA2_HUMAN	INHIBITOR	Kd	9.07	CHEMBL	CHEMBL
Platelet-derived growth factor receptor beta	Kinase	P09619	PGFRB_HUMAN	INHIBITOR	Kd	9.20	CHEMBL	CHEMBL
Serine/threonine-protein kinase B-raf	Kinase	P15056	BRAF_HUMAN		Kd	6.30	CHEMBL
Receptor-type tyrosine-protein kinase FLT3	Kinase	P36888	FLT3_HUMAN		Kd	5.49	CHEMBL
Proto-oncogene tyrosine-protein kinase receptor Ret	Kinase	P07949	RET_HUMAN		Kd	6.41	CHEMBL
Vascular endothelial growth factor receptor 1	Kinase	P17948	VGFR1_HUMAN		Kd	5.30	CHEMBL
Vascular endothelial growth factor receptor 2	Kinase	P35968	VGFR2_HUMAN		Kd	5.54	CHEMBL
Macrophage colony-stimulating factor 1 receptor	Kinase	P07333	CSF1R_HUMAN		Kd	9.24	CHEMBL
Platelet-derived growth factor receptor alpha	Kinase	P16234	PGFRA_HUMAN		Kd	9.33	CHEMBL
Receptor tyrosine-protein kinase erbB-2	Kinase	P04626	ERBB2_HUMAN		Kd	5.85	CHEMBL
Myosin light chain kinase, smooth muscle	Kinase	Q15746	MYLK_HUMAN		Kd	7.14	CHEMBL
Fibroblast growth factor receptor 3	Kinase	P22607	FGFR3_HUMAN		Kd	5.41	CHEMBL
Tyrosine-protein kinase HCK	Kinase	P08631	HCK_HUMAN	INHIBITOR	Kd	9.46	CHEMBL
Receptor tyrosine-protein kinase erbB-4	Kinase	Q15303	ERBB4_HUMAN		Kd	7.26	CHEMBL
Phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit delta isoform	Kinase	O00329	PK3CD_HUMAN		IC50	4.52	CHEMBL
cAMP-dependent protein kinase catalytic subunit beta	Kinase	P22694	KAPCB_HUMAN		Kd	5.92	CHEMBL
Tyrosine-protein kinase JAK2	Kinase	O60674	JAK2_HUMAN		Kd	6	CHEMBL
Tyrosine-protein kinase SYK	Kinase	P43405	KSYK_HUMAN		Kd	5.54	CHEMBL
Myosin light chain kinase 2, skeletal/cardiac muscle	Kinase	Q9H1R3	MYLK2_HUMAN		Kd	5.46	CHEMBL
Tyrosine-protein kinase CSK	Kinase	P41240	CSK_HUMAN		Kd	9	CHEMBL
Ephrin type-A receptor 8	Kinase	P29322	EPHA8_HUMAN		Kd	9.62	CHEMBL
Tyrosine-protein kinase Lyn	Kinase	P07948	LYN_HUMAN	INHIBITOR	Kd	9.24	CHEMBL
Cytoplasmic tyrosine-protein kinase BMX	Kinase	P51813	BMX_HUMAN		Kd	8.85	CHEMBL
Serine/threonine-protein kinase Nek2	Kinase	P51955	NEK2_HUMAN		Kd	5.19	CHEMBL
LIM domain kinase 1	Kinase	P53667	LIMK1_HUMAN		Kd	6.24	CHEMBL
Fibroblast growth factor receptor 1	Kinase	P11362	FGFR1_HUMAN		Kd	5.43	CHEMBL
Serine/threonine-protein kinase 10	Kinase	O94804	STK10_HUMAN		Kd	5.92	CHEMBL
Abelson tyrosine-protein kinase 2	Kinase	P42684	ABL2_HUMAN		Kd	9.77	CHEMBL
Mitogen-activated protein kinase 11	Kinase	Q15759	MK11_HUMAN		Kd	6.39	CHEMBL
Ephrin type-A receptor 5	Kinase	P54756	EPHA5_HUMAN		Kd	9.62	CHEMBL
Ephrin type-A receptor 4	Kinase	P54764	EPHA4_HUMAN		Kd	8.92	CHEMBL
Fibroblast growth factor receptor 2	Kinase	P21802	FGFR2_HUMAN		Kd	5.85	CHEMBL
Serine/threonine-protein kinase N1	Kinase	Q16512	PKN1_HUMAN		Kd	6.45	CHEMBL
Protein kinase C theta type	Kinase	Q04759	KPCT_HUMAN		Kd	6.15	CHEMBL
Ephrin type-A receptor 6	Kinase	Q9UF33	EPHA6_HUMAN		Kd	5.68	CHEMBL
TRAF2 and NCK-interacting protein kinase	Kinase	Q9UKE5	TNIK_HUMAN		Kd	5.70	CHEMBL
Casein kinase I isoform epsilon	Kinase	P49674	KC1E_HUMAN		Kd	5.82	CHEMBL
Tyrosine-protein kinase Fgr	Kinase	P09769	FGR_HUMAN	INHIBITOR	Kd	9.30	CHEMBL
Aurora kinase A	Kinase	O14965	AURKA_HUMAN		Kd	5.03	CHEMBL
Serine/threonine-protein kinase 36	Kinase	Q9NRP7	STK36_HUMAN		Kd	6.68	CHEMBL
Ephrin type-A receptor 3	Kinase	P29320	EPHA3_HUMAN		Kd	10.03	CHEMBL
Mitogen-activated protein kinase 14	Kinase	Q16539	MK14_HUMAN		Kd	7.57	CHEMBL
Tyrosine-protein kinase FRK	Kinase	P42685	FRK_HUMAN	INHIBITOR	Kd	9.51	CHEMBL
Mitogen-activated protein kinase kinase kinase kinase 5	Kinase	Q9Y4K4	M4K5_HUMAN		Kd	7.35	CHEMBL
Mitogen-activated protein kinase kinase kinase 4	Kinase	Q9Y6R4	M3K4_HUMAN		Kd	6.51	CHEMBL
Cyclin-G-associated kinase	Kinase	O14976	GAK_HUMAN		Kd	8.59	CHEMBL
Receptor-interacting serine/threonine-protein kinase 2	Kinase	O43353	RIPK2_HUMAN		Kd	7.51	CHEMBL
Ephrin type-B receptor 1	Kinase	P54762	EPHB1_HUMAN		Kd	9.35	CHEMBL
Serine/threonine-protein kinase 4	Kinase	Q13043	STK4_HUMAN		Kd	5.42	CHEMBL
Activated CDC42 kinase 1	Kinase	Q07912	ACK1_HUMAN		Kd	8.25	CHEMBL
STE20-like serine/threonine-protein kinase	Kinase	Q9H2G2	SLK_HUMAN		Kd	6.14	CHEMBL
Epithelial discoidin domain-containing receptor 1	Kinase	Q08345	DDR1_HUMAN		Kd	9.16	CHEMBL
Ephrin type-B receptor 4	Kinase	P54760	EPHB4_HUMAN		Kd	9.47	CHEMBL
Activin receptor type-1B	Kinase	P36896	ACV1B_HUMAN		Kd	6.48	CHEMBL
Serine/threonine-protein kinase receptor R3	Kinase	P37023	ACVL1_HUMAN		Kd	6.34	CHEMBL
Activin receptor type-1	Kinase	Q04771	ACVR1_HUMAN		Kd	6.21	CHEMBL
TGF-beta receptor type-2	Kinase	P37173	TGFR2_HUMAN		Kd	5.54	CHEMBL
Dual specificity mitogen-activated protein kinase kinase 1	Kinase	Q02750	MP2K1_HUMAN		Kd	6	CHEMBL
Dual specificity mitogen-activated protein kinase kinase 2	Kinase	P36507	MP2K2_HUMAN		Kd	5.85	CHEMBL
Tyrosine-protein kinase ITK/TSK	Kinase	Q08881	ITK_HUMAN		IC50	6.64	CHEMBL
Protein-tyrosine kinase 6	Kinase	Q13882	PTK6_HUMAN		Kd	8.11	CHEMBL
MAP kinase-activated protein kinase 2	Kinase	P49137	MAPK2_HUMAN		Kd	6.27	CHEMBL
Tyrosine-protein kinase BTK	Kinase	Q06187	BTK_HUMAN		Kd	8.85	CHEMBL
Tyrosine-protein kinase Tec	Kinase	P42680	TEC_HUMAN		Kd	7.89	CHEMBL
Ephrin type-B receptor 2	Kinase	P29323	EPHB2_HUMAN		Kd	9.41	CHEMBL
Non-receptor tyrosine-protein kinase TNK1	Kinase	Q13470	TNK1_HUMAN		Kd	6.17	CHEMBL
Non-receptor tyrosine-protein kinase TYK2	Kinase	P29597	TYK2_HUMAN		Kd	6.96	CHEMBL
Phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit alpha isoform	Kinase	P42336	PK3CA_HUMAN		IC50	4.42	CHEMBL
Wee1-like protein kinase	Kinase	P30291	WEE1_HUMAN		Kd	5.15	CHEMBL
Serine/threonine-protein kinase 25	Kinase	O00506	STK25_HUMAN		Kd	5.47	CHEMBL
Mitogen-activated protein kinase kinase kinase MLT	Kinase	Q9NYL2	MLTK_HUMAN		Kd	7.35	CHEMBL
Tyrosine-protein kinase TXK	Kinase	P42681	TXK_HUMAN		Kd	8.68	CHEMBL
LIM domain kinase 2	Kinase	P53671	LIMK2_HUMAN		Kd	7.07	CHEMBL
Serine/threonine-protein kinase 26	Kinase	Q9P289	STK26_HUMAN		Kd	5.72	CHEMBL
Serine/threonine-protein kinase NLK	Kinase	Q9UBE8	NLK_HUMAN		Kd	6.59	CHEMBL
Eukaryotic translation initiation factor 2-alpha kinase 4	Kinase	Q9P2K8	E2AK4_HUMAN		Kd	5.80	CHEMBL
Serine/threonine-protein kinase SIK2	Kinase	Q9H0K1	SIK2_HUMAN		Kd	8.19	CHEMBL
Activin receptor type-2A	Kinase	P27037	AVR2A_HUMAN		Kd	6.68	CHEMBL
Activin receptor type-2B	Kinase	Q13705	AVR2B_HUMAN		Kd	6.24	CHEMBL
Serine/threonine-protein kinase TNNI3K	Kinase	Q59H18	TNI3K_HUMAN		Kd	7.96	CHEMBL
Discoidin domain-containing receptor 2	Kinase	Q16832	DDR2_HUMAN		Kd	8.52	CHEMBL
Myotonin-protein kinase	Kinase	Q09013	DMPK_HUMAN		Kd	5.89	CHEMBL
Chaperone activity of bc1 complex-like, mitochondrial	Kinase	Q8NI60	COQ8A_HUMAN		Kd	6.72	CHEMBL
Serine/threonine-protein kinase MRCK gamma	Kinase	Q6DT37	MRCKG_HUMAN		Kd	5.92	CHEMBL
Mitogen-activated protein kinase kinase kinase kinase 1	Kinase	Q92918	M4K1_HUMAN		Kd	6.01	CHEMBL
Membrane-associated tyrosine- and threonine-specific cdc2-inhibitory kinase	Kinase	Q99640	PMYT1_HUMAN		Kd	6.89	CHEMBL
Mitogen-activated protein kinase kinase kinase kinase 3	Kinase	Q8IVH8	M4K3_HUMAN		Kd	6.19	CHEMBL
Aurora kinase B	Kinase	Q96GD4	AURKB_HUMAN		IC50	5.19	CHEMBL
Tyrosine-protein kinase Blk	Kinase	P51451	BLK_HUMAN	INHIBITOR	Kd	9.68	CHEMBL
Bone morphogenetic protein receptor type-1A	Kinase	P36894	BMR1A_HUMAN		Kd	5.15	CHEMBL
Mitogen-activated protein kinase kinase kinase kinase 4	Kinase	O95819	M4K4_HUMAN		Kd	5.51	CHEMBL
Serine/threonine-protein kinase MRCK alpha	Kinase	Q5VT25	MRCKA_HUMAN		Kd	5.70	CHEMBL
Serine/threonine-protein kinase MRCK beta	Kinase	Q9Y5S2	MRCKB_HUMAN		Kd	5.68	CHEMBL
Serine/threonine-protein kinase PAK 4	Kinase	O96013	PAK4_HUMAN		Kd	6.13	CHEMBL
Serine/threonine-protein kinase SIK1	Kinase	P57059	SIK1_HUMAN		Kd	8.41	CHEMBL
Tyrosine-protein kinase Srms	Kinase	Q9H3Y6	SRMS_HUMAN	INHIBITOR	Kd	7.89	CHEMBL
Dual specificity testis-specific protein kinase 1	Kinase	Q15569	TESK1_HUMAN		Kd	7.48	CHEMBL
TGF-beta receptor type-1	Kinase	P36897	TGFR1_HUMAN		Kd	6.64	CHEMBL
Ephrin type-A receptor 1	Kinase	P21709	EPHA1_HUMAN		Kd	8.39	CHEMBL
Ephrin type-B receptor 3	Kinase	P54753	EPHB3_HUMAN		Kd	8.16	CHEMBL
Mitogen-activated protein kinase kinase kinase kinase 2	Kinase	Q12851	M4K2_HUMAN		Kd	5.89	CHEMBL
Misshapen-like kinase 1	Kinase	Q8N4C8	MINK1_HUMAN		Kd	6.37	CHEMBL
Ephrin type-B receptor 6	Kinase	O15197	EPHB6_HUMAN		Kd	10.41	CHEMBL
Mitogen-activated protein kinase kinase kinase 13	Kinase	O43283	M3K13_HUMAN		Kd	5.28	CHEMBL
Mitogen-activated protein kinase kinase kinase 2	Kinase	Q9Y2U5	M3K2_HUMAN		Kd	6.85	CHEMBL
Mitogen-activated protein kinase kinase kinase 3	Kinase	Q99759	M3K3_HUMAN		Kd	6.55	CHEMBL
Mitogen-activated protein kinase kinase kinase 7	Kinase	O43318	M3K7_HUMAN		Kd	5.43	CHEMBL
Serine/threonine-protein kinase TAO3	Kinase	Q9H2K8	TAOK3_HUMAN		Kd	5.64	CHEMBL
Serine/threonine-protein kinase ULK3	Kinase	Q6PHR2	ULK3_HUMAN		Kd	5.34	CHEMBL
Mitogen-activated protein kinase kinase kinase 19	Kinase	Q56UN5	M3K19_HUMAN		Kd	7.10	CHEMBL
Serine/threonine-protein kinase 35	Kinase	Q8TDR2	STK35_HUMAN		Kd	6.11	CHEMBL
Receptor tyrosine-protein kinase erbB-3	Kinase	P21860	ERBB3_HUMAN		Kd	7.74	CHEMBL
Mitogen-activated protein kinase kinase kinase 1	Kinase	Q13233	M3K1_HUMAN		Kd	5.90	CHEMBL
Serine/threonine-protein kinase SIK3	Kinase	Q9Y2K2	SIK3_HUMAN		Kd	7.55	CHEMBL
Wee1-like protein kinase 2	Kinase	P0C1S8	WEE2_HUMAN		Kd	6.70	CHEMBL
Bone morphogenetic protein receptor type-1B	Kinase	O00238	BMR1B_HUMAN		Kd	7.28	CHEMBL
Serine/threonine-protein kinase SBK1	Kinase	Q52WX2	SBK1_HUMAN		Kd	5.92	CHEMBL
Serine/threonine-protein kinase VRK2	Kinase	Q86Y07	VRK2_HUMAN		Kd	5.49	CHEMBL
Serine/threonine-protein kinase TAO2	Kinase	Q9UL54	TAOK2_HUMAN		Kd	5.27	CHEMBL
Dual specificity mitogen-activated protein kinase kinase 5	Kinase	Q13163	MP2K5_HUMAN		Kd	8.48	CHEMBL
Serine/threonine-protein kinase Nek11	Kinase	Q8NG66	NEK11_HUMAN		Kd	6.33	CHEMBL
MAP kinase p38	Kinase	O15264 P53778 Q15759 Q16539	MK13_HUMAN MK12_HUMAN MK11_HUMAN MK14_HUMAN		IC50	7	CHEMBL
Dual specificity mitogen-activated protein kinase kinase; MEK1/2	Kinase	P36507 Q02750	MP2K2_HUMAN MP2K1_HUMAN		IC50	5.77	CHEMBL
Bcr/Abl fusion protein	Kinase	P00519 P11274	ABL1_HUMAN BCR_HUMAN		IC50	9.10	CHEMBL
RAF proto-oncogene serine/threonine-protein kinase	Kinase	P04049	RAF1_HUMAN		Kd	6.24	CHEMBL
Myelin transcription factor 1	Transcription factor	Q01538	MYT1_HUMAN		IC50	7.20	CHEMBL
Tyrosine-protein kinase JAK3	Kinase	P52333	JAK3_HUMAN		Kd	6.19	CHEMBL
Potassium voltage-gated channel subfamily H member 2	Ion channel	Q12809	KCNH2_HUMAN		IC50	4.84	CHEMBL
Transthyretin	Secreted	P02766	TTHY_HUMAN		Kd	5.51	CHEMBL
ATP-binding cassette sub-family G member 2	Transporter	Q9UNQ0	ABCG2_HUMAN		IC50	5.70	CHEMBL
Epidermal growth factor receptor	Kinase	P00533	EGFR_HUMAN		Kd	7.10	CHEMBL
Serine/threonine-protein kinase mTOR	Kinase	P42345	MTOR_HUMAN		IC50	4.46	CHEMBL
Breakpoint cluster region protein	Kinase	P11274	BCR_HUMAN		Kd	8.30	CHEMBL
Proto-oncogene tyrosine-protein kinase LCK	Kinase		LCK_MOUSE		Ki	10.19	CHEMBL
Proto-oncogene tyrosine-protein kinase Src	Kinase		SRC_CHICK		Kd	7.96	CHEMBL
Tubulin alpha-1A chain	Structural		TBA1A_RAT		Kd	7.26	CHEMBL
Tyrosine-protein kinase Blk	Kinase		BLK_MOUSE		IC50	8.10	CHEMBL
Quinolone resistance protein NorA	Transporter		NORA_STAAU		IC50	4.94	CHEMBL
Calcium-dependent protein kinase 1	Kinase		CDPK1_PLAF7		Kd	6.19	CHEMBL

External reference:

ID	Source
4025488	VUID
N0000179780	NUI
D03658	KEGG_DRUG
863127-77-9	SECONDARY_CAS_RN
475342	RXNORM
C1455147	UMLSCUI
CHEBI:70839	CHEBI
1N1	PDB_CHEM_ID
CHEMBL5416410	ChEMBL_ID
CHEMBL1421	ChEMBL_ID
D000069439	MESH_DESCRIPTOR_UI
DB01254	DRUGBANK_ID
5678	IUPHAR_LIGAND_ID
RBZ1571X5H	UNII
3062316	PUBCHEM_CID
21648	MMSL
293976	MMSL
83173	MMSL
d05831	MMSL
011616	NDDF
422756008	SNOMEDCT_US
423658008	SNOMEDCT_US
4025488	VANDF
RBZ1571X5H	INXIGHT DRUGS

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
SPRYCEL	HUMAN PRESCRIPTION DRUG LABEL	1	0003-0524	TABLET	70 mg	ORAL	NDA	26 sections
SPRYCEL	HUMAN PRESCRIPTION DRUG LABEL	1	0003-0527	TABLET	20 mg	ORAL	NDA	26 sections
SPRYCEL	HUMAN PRESCRIPTION DRUG LABEL	1	0003-0528	TABLET	50 mg	ORAL	NDA	26 sections
SPRYCEL	HUMAN PRESCRIPTION DRUG LABEL	1	0003-0852	TABLET	100 mg	ORAL	NDA	26 sections
SPRYCEL	HUMAN PRESCRIPTION DRUG LABEL	1	0003-0855	TABLET	80 mg	ORAL	NDA	26 sections
SPRYCEL	HUMAN PRESCRIPTION DRUG LABEL	1	0003-0857	TABLET	140 mg	ORAL	NDA	26 sections
Dasatinib	HUMAN PRESCRIPTION DRUG LABEL	1	0480-3523	TABLET, FILM COATED	80 mg	ORAL	ANDA	28 sections
Dasatinib	HUMAN PRESCRIPTION DRUG LABEL	1	0480-3524	TABLET, FILM COATED	140 mg	ORAL	ANDA	28 sections
Dasatinib	HUMAN PRESCRIPTION DRUG LABEL	1	0480-5101	TABLET, FILM COATED	20 mg	ORAL	ANDA	28 sections
Dasatinib	HUMAN PRESCRIPTION DRUG LABEL	1	0480-5102	TABLET, FILM COATED	50 mg	ORAL	ANDA	28 sections
Dasatinib	HUMAN PRESCRIPTION DRUG LABEL	1	0480-5103	TABLET, FILM COATED	70 mg	ORAL	ANDA	28 sections
Dasatinib	HUMAN PRESCRIPTION DRUG LABEL	1	0480-5104	TABLET, FILM COATED	100 mg	ORAL	ANDA	28 sections
Dasatinib	HUMAN PRESCRIPTION DRUG LABEL	1	43598-599	TABLET, FILM COATED	20 mg	ORAL	ANDA	24 sections
Dasatinib	HUMAN PRESCRIPTION DRUG LABEL	1	43598-600	TABLET, FILM COATED	50 mg	ORAL	ANDA	24 sections
Dasatinib	HUMAN PRESCRIPTION DRUG LABEL	1	43598-601	TABLET, FILM COATED	70 mg	ORAL	ANDA	24 sections
Dasatinib	HUMAN PRESCRIPTION DRUG LABEL	1	43598-602	TABLET, FILM COATED	80 mg	ORAL	ANDA	24 sections
Dasatinib	HUMAN PRESCRIPTION DRUG LABEL	1	43598-603	TABLET, FILM COATED	100 mg	ORAL	ANDA	24 sections
Dasatinib	HUMAN PRESCRIPTION DRUG LABEL	1	43598-604	TABLET, FILM COATED	140 mg	ORAL	ANDA	24 sections
DASATINIB	Human Prescription Drug Label	1	46708-684	TABLET, FILM COATED	20 mg	ORAL	ANDA	28 sections
DASATINIB	Human Prescription Drug Label	1	46708-685	TABLET, FILM COATED	50 mg	ORAL	ANDA	28 sections
DASATINIB	Human Prescription Drug Label	1	46708-686	TABLET, FILM COATED	70 mg	ORAL	ANDA	28 sections
DASATINIB	Human Prescription Drug Label	1	46708-687	TABLET, FILM COATED	80 mg	ORAL	ANDA	28 sections
DASATINIB	Human Prescription Drug Label	1	46708-688	TABLET, FILM COATED	100 mg	ORAL	ANDA	28 sections
DASATINIB	Human Prescription Drug Label	1	46708-689	TABLET, FILM COATED	140 mg	ORAL	ANDA	28 sections
SPRYCEL	HUMAN PRESCRIPTION DRUG LABEL	1	54868-5759	TABLET	70 mg	ORAL	NDA	28 sections
DASATINIB	Human Prescription Drug Label	1	59651-542	TABLET	20 mg	ORAL	ANDA	28 sections
DASATINIB	Human Prescription Drug Label	1	59651-543	TABLET	50 mg	ORAL	ANDA	28 sections
DASATINIB	Human Prescription Drug Label	1	59651-544	TABLET	70 mg	ORAL	ANDA	28 sections
DASATINIB	Human Prescription Drug Label	1	59651-545	TABLET	80 mg	ORAL	ANDA	28 sections
DASATINIB	Human Prescription Drug Label	1	59651-546	TABLET	100 mg	ORAL	ANDA	28 sections