idarubicin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
antineoplastics, daunorubicin derivatives	1414	58957-92-9

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: idarubicin 4-Demethoxydaunomycin 4-Demethoxydaunorubicin demethoxydaunorubicin idarubicin hydrochloride idarubicin HCl	An orally administered anthracycline antineoplastic. The compound has shown activity against BREAST NEOPLASMS; LYMPHOMA; and LEUKEMIA. Molecular weight: 497.50 Formula: C26H27NO9 CLOGP: 0.84 LIPINSKI: 0 HAC: 10 HDO: 5 TPSA: 176.61 ALOGS: -2.81 ROTB: 3 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

idarubicin
4-Demethoxydaunomycin
4-Demethoxydaunorubicin
demethoxydaunorubicin
idarubicin hydrochloride
idarubicin HCl

An orally administered anthracycline antineoplastic. The compound has shown activity against BREAST NEOPLASMS; LYMPHOMA; and LEUKEMIA.

Molecular weight: 497.50
Formula: C26H27NO9
CLOGP: 0.84
LIPINSKI: 0
HAC: 10
HDO: 5
TPSA: 176.61
ALOGS: -2.81
ROTB: 3

Status: OFP

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

Drug dosage:

None

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	3 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	5.43 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	28 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	38 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	24 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.08 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	16 hours	Lombardo F, Berellini G, Obach RS
S (Water solubility)	10 mg/mL	Bocci G, Oprea TI, Benet LZ

Approvals:

Date	Agency	Company	Orphan
Sept. 27, 1990	FDA

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
Febrile neutropenia	578.72	38.26	252	5065	118197	63365508
Differentiation syndrome	203.08	38.26	40	5277	1063	63482642
Acute myeloid leukaemia recurrent	170.71	38.26	37	5280	1586	63482119
Fusarium infection	153.38	38.26	29	5288	617	63483088
Neutropenia	148.03	38.26	120	5197	174885	63308820
Neutropenic colitis	146.95	38.26	37	5280	3058	63480647
Geotrichum infection	136.23	38.26	25	5292	449	63483256
Thrombocytopenia	130.61	38.26	105	5212	151052	63332653
Septic shock	125.91	38.26	75	5242	66554	63417151
Mucosal inflammation	121.66	38.26	65	5252	46863	63436842
Bone marrow failure	118.77	38.26	55	5262	29235	63454470
Neoplasm recurrence	107.87	38.26	28	5289	2610	63481095
Acute myeloid leukaemia	104.77	38.26	43	5274	17104	63466601
Multiple organ dysfunction syndrome	102.30	38.26	62	5255	56690	63427015
Pancytopenia	95.85	38.26	73	5244	96860	63386845
Sepsis	90.99	38.26	86	5231	153037	63330668
Leukaemia recurrent	83.84	38.26	20	5297	1318	63482387
Myelosuppression	82.25	38.26	40	5277	23663	63460042
Second primary malignancy	81.18	38.26	29	5288	7924	63475781
Acute lymphocytic leukaemia recurrent	73.35	38.26	20	5297	2249	63481456
Bronchopulmonary aspergillosis	64.35	38.26	25	5292	8610	63475095
Febrile bone marrow aplasia	61.02	38.26	23	5294	7302	63476403
Gene mutation	60.05	38.26	16	5301	1649	63482056
Neurotoxicity	59.92	38.26	29	5288	16961	63466744
Haemophagocytic lymphohistiocytosis	59.33	38.26	25	5292	10602	63473103
Disseminated intravascular coagulation	56.77	38.26	29	5288	19022	63464683
Endophthalmitis	55.98	38.26	18	5299	3574	63480131
Lower respiratory tract infection fungal	54.60	38.26	11	5306	328	63483377
Pneumonia fungal	52.32	38.26	19	5298	5436	63478269
Ventricular hypokinesia	47.63	38.26	17	5300	4627	63479078
Mucormycosis	47.26	38.26	15	5302	2856	63480849
Ejection fraction decreased	47.01	38.26	27	5290	22305	63461400
Dedifferentiated liposarcoma	45.54	38.26	7	5310	39	63483666
Aspergillus infection	45.04	38.26	19	5298	8074	63475631
Neutropenic sepsis	43.19	38.26	23	5294	16415	63467290
Myelodysplastic syndrome	42.77	38.26	23	5294	16731	63466974
Hyperbilirubinaemia	41.98	38.26	20	5297	11294	63472411
Fungaemia	41.40	38.26	13	5304	2390	63481315
Cytarabine syndrome	40.93	38.26	7	5310	82	63483623
Cytomegalovirus infection	40.58	38.26	24	5293	20928	63462777
Pain	40.04	38.26	7	5310	740621	62743084
Leukoerythroblastosis	39.95	38.26	8	5309	231	63483474
Product use in unapproved indication	39.78	38.26	61	5256	179019	63304686
Chromosomal deletion	39.51	38.26	7	5310	102	63483603
Neutropenic infection	39.34	38.26	11	5306	1356	63482349
Haematopoietic neoplasm	38.52	38.26	6	5311	37	63483668

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
Febrile neutropenia	496.28	29.85	309	6146	136540	34813936
Neutropenia	163.24	29.85	171	6284	156607	34793869
Acute myeloid leukaemia recurrent	158.60	29.85	43	6412	2127	34948349
Bronchopulmonary aspergillosis	141.44	29.85	64	6391	14595	34935881
Fungal infection	124.10	29.85	60	6395	15875	34934601
Differentiation syndrome	121.68	29.85	32	6423	1406	34949070
Bone marrow failure	112.49	29.85	69	6386	29184	34921292
Mucormycosis	101.47	29.85	39	6416	5903	34944573
Acute myeloid leukaemia	93.79	29.85	52	6403	18218	34932258
Myelodysplastic syndrome	88.68	29.85	51	6404	19157	34931319
Septic shock	88.43	29.85	86	6369	71748	34878728
Pancytopenia	85.07	29.85	96	6359	95061	34855415
Aspergillus infection	77.27	29.85	40	6415	12214	34938262
Venoocclusive liver disease	74.33	29.85	34	6421	7932	34942544
Thrombocytopenia	72.06	29.85	114	6341	156133	34794343
Fusarium infection	70.98	29.85	20	6435	1140	34949336
Neutropenic colitis	69.69	29.85	25	6430	3119	34947357
Pneumonia fungal	62.17	29.85	29	6426	7071	34943405
Febrile bone marrow aplasia	61.14	29.85	30	6425	8179	34942297
Sepsis	58.87	29.85	108	6347	166453	34784023
Aeromonas infection	58.73	29.85	13	6442	271	34950205
Cytomegalovirus infection reactivation	54.62	29.85	24	6431	5094	34945382
Myelosuppression	50.96	29.85	36	6419	19229	34931247
Stenotrophomonas infection	47.60	29.85	17	6438	2093	34948383
Second primary malignancy	47.58	29.85	25	6430	7861	34942615
Neoplasm progression	47.00	29.85	37	6418	23263	34927213
Geotrichum infection	46.42	29.85	12	6443	492	34949984
Mucosal inflammation	45.14	29.85	45	6410	38577	34911899
Pyrexia	42.30	29.85	146	6309	332867	34617609
Chronic graft versus host disease	41.84	29.85	19	6436	4354	34946122
Product use in unapproved indication	39.94	29.85	75	6380	117424	34833052
Haematopoietic neoplasm	38.64	29.85	7	6448	49	34950427
Adenomatous polyposis coli	36.85	29.85	8	6447	152	34950324
Poikiloderma	35.73	29.85	8	6447	176	34950300
Neoplasm recurrence	35.68	29.85	14	6441	2235	34948241
Premature ageing	35.56	29.85	7	6448	80	34950396
Rhabdomyosarcoma recurrent	33.86	29.85	7	6448	104	34950372
Drug resistance	33.64	29.85	32	6423	25895	34924581
T-cell type acute leukaemia	32.81	29.85	7	6448	122	34950354
Myocarditis	32.59	29.85	24	6431	13658	34936818
Reticulocytosis	32.39	29.85	8	6447	272	34950204
Hyperbilirubinaemia	32.36	29.85	26	6429	16817	34933659
Infection	30.83	29.85	58	6397	90857	34859619
Recurrent cancer	30.63	29.85	11	6444	1376	34949100
Escherichia bacteraemia	30.59	29.85	14	6441	3266	34947210
Acute graft versus host disease in skin	29.99	29.85	16	6439	5185	34945291

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
Febrile neutropenia	1002.63	25.81	539	11038	230460	79502351
Differentiation syndrome	298.25	25.81	70	11507	2454	79730357
Neutropenia	276.05	25.81	269	11308	287441	79445370
Acute myeloid leukaemia recurrent	248.34	25.81	64	11513	3319	79729492
Fusarium infection	243.99	25.81	56	11521	1776	79731035
Neutropenic colitis	219.57	25.81	65	11512	5642	79727169
Bone marrow failure	219.19	25.81	119	11458	50988	79681823
Septic shock	203.22	25.81	157	11420	122644	79610167
Acute myeloid leukaemia	187.75	25.81	91	11486	30794	79702017
Pancytopenia	185.40	25.81	169	11408	165576	79567235
Bronchopulmonary aspergillosis	176.89	25.81	79	11498	22215	79710596
Thrombocytopenia	175.82	25.81	204	11373	265055	79467756
Myelodysplastic syndrome transformation	170.17	25.81	35	11542	654	79732157
Geotrichum infection	168.92	25.81	37	11540	944	79731867
Fungal infection	137.91	25.81	82	11495	41666	79691145
Second primary malignancy	137.16	25.81	58	11519	14292	79718519
Myelodysplastic syndrome	125.52	25.81	69	11508	30232	79702579
Sepsis	124.11	25.81	173	11404	269255	79463556
Mucosal inflammation	121.34	25.81	95	11482	75485	79657326
Myelosuppression	114.78	25.81	72	11505	40224	79692587
Pneumonia fungal	112.78	25.81	47	11530	11163	79721648
Neoplasm recurrence	111.36	25.81	36	11541	4178	79728633
Mucormycosis	111.15	25.81	43	11534	8426	79724385
Aspergillus infection	106.09	25.81	53	11524	19108	79713703
Venoocclusive liver disease	94.26	25.81	42	11535	11729	79721082
Febrile bone marrow aplasia	87.11	25.81	41	11536	12979	79719832
Multiple organ dysfunction syndrome	85.37	25.81	96	11481	120150	79612661
Acute lymphocytic leukaemia recurrent	76.58	25.81	28	11549	4696	79728115
Haematopoietic neoplasm	76.19	25.81	13	11564	81	79732730
Hyperbilirubinaemia	72.80	25.81	45	11532	24473	79708338
Pain	71.69	25.81	9	11568	703793	79029018
Product use in unapproved indication	71.13	25.81	129	11448	250230	79482581
Leukaemia recurrent	70.46	25.81	23	11554	2751	79730060
Stenotrophomonas infection	67.29	25.81	24	11553	3749	79729062
Pyrexia	62.55	25.81	228	11349	678481	79054330
Fungaemia	59.14	25.81	23	11554	4568	79728243
Drug resistance	59.07	25.81	49	11528	42164	79690647
Aeromonas infection	58.21	25.81	13	11564	363	79732448
Neoplasm progression	58.21	25.81	53	11524	51629	79681182
Haemophagocytic lymphohistiocytosis	57.13	25.81	37	11540	21800	79711011
Myocarditis	54.84	25.81	36	11541	21697	79711114
Arthralgia	54.25	25.81	9	11568	571794	79161017
Pathogen resistance	52.15	25.81	30	11547	14312	79718499
Bacteraemia	52.06	25.81	41	11536	32783	79700028
Dizziness	50.58	25.81	8	11569	526433	79206378
Pneumonia	50.33	25.81	209	11368	660037	79072774
Neutropenic infection	49.26	25.81	17	11560	2410	79730401
Fatigue	49.22	25.81	38	11539	929689	78803122
Disseminated intravascular coagulation	48.89	25.81	41	11536	35801	79697010
Cytarabine syndrome	48.36	25.81	9	11568	97	79732714
Cytomegalovirus infection reactivation	47.91	25.81	24	11553	8692	79724119
Fall	47.77	25.81	7	11570	487622	79245189
Cytomegalovirus infection	46.59	25.81	43	11534	42601	79690210
Respiratory failure	46.05	25.81	89	11488	180822	79551989
Dysplasia	45.60	25.81	14	11563	1372	79731439
Ventricular hypokinesia	43.63	25.81	23	11554	9256	79723555
Graft versus host disease	43.14	25.81	27	11550	14999	79717812
Lower respiratory tract infection fungal	42.54	25.81	12	11565	876	79731935
Acute respiratory distress syndrome	41.61	25.81	41	11536	44026	79688785
Tumour lysis syndrome	40.35	25.81	31	11546	23908	79708903
Escherichia bacteraemia	38.83	25.81	19	11558	6543	79726268
Rash maculo-papular	38.44	25.81	44	11533	56034	79676777
Ejection fraction decreased	38.03	25.81	35	11542	34542	79698269
Premature ageing	36.77	25.81	7	11570	86	79732725
Infective aneurysm	36.67	25.81	11	11566	997	79731814
Recurrent cancer	36.49	25.81	14	11563	2679	79730132
Pulmonary haemorrhage	36.21	25.81	24	11553	14693	79718118
Cytopenia	35.68	25.81	27	11550	20356	79712455
Chronic graft versus host disease	35.31	25.81	18	11559	6763	79726048
Adenomatous polyposis coli	35.20	25.81	8	11569	242	79732569
Chloroma	35.05	25.81	10	11567	760	79732051
Weight decreased	34.99	25.81	5	11572	355193	79377618
Enterococcal bacteraemia	34.72	25.81	14	11563	3054	79729757
Haemorrhagic pneumonia	33.97	25.81	7	11570	132	79732679
Leukoerythroblastosis	33.44	25.81	8	11569	304	79732507
Aplasia	32.89	25.81	18	11559	7802	79725009
Chromosomal deletion	32.64	25.81	7	11570	161	79732650
Streptococcal bacteraemia	32.54	25.81	14	11563	3592	79729219
Colitis	32.03	25.81	46	11531	73261	79659550
T-cell type acute leukaemia	31.75	25.81	7	11570	184	79732627
Hidradenitis	31.41	25.81	13	11564	3031	79729780
Poikiloderma	31.41	25.81	8	11569	395	79732416
Cardiomyopathy	31.40	25.81	29	11548	28745	79704066
Malaise	31.38	25.81	16	11561	489853	79242958
Acute graft versus host disease in skin	30.49	25.81	17	11560	7641	79725170
Reticulocytosis	29.55	25.81	8	11569	501	79732310
Gamma-glutamyltransferase increased	29.48	25.81	38	11539	54642	79678169
Pleural effusion	29.34	25.81	65	11512	145197	79587614
Peripheral swelling	28.49	25.81	3	11574	269614	79463197
Necrotising fasciitis	28.45	25.81	15	11562	6035	79726776
Neurotoxicity	28.39	25.81	29	11548	32489	79700322
Dyspnoea	28.17	25.81	51	11526	856974	78875837
Haematotoxicity	28.15	25.81	21	11556	15498	79717313
Pharyngeal inflammation	28.03	25.81	9	11568	1021	79731790
Anti-platelet antibody positive	28.03	25.81	7	11570	319	79732492
Posterior reversible encephalopathy syndrome	27.73	25.81	26	11551	26255	79706556
Endophthalmitis	27.60	25.81	15	11562	6413	79726398
Cytogenetic abnormality	27.25	25.81	9	11568	1116	79731695
Philadelphia chromosome positive	27.15	25.81	8	11569	682	79732129
Large granular lymphocytosis	26.91	25.81	7	11570	376	79732435
Blood bilirubin increased	26.68	25.81	40	11537	66192	79666619
Pseudomonas infection	26.64	25.81	23	11554	20880	79711931
Primary hypogonadism	26.42	25.81	6	11571	181	79732630
Pain in extremity	26.34	25.81	10	11567	364528	79368283
Raoultella ornithinolytica infection	26.30	25.81	5	11572	61	79732750
Pericardial effusion	26.30	25.81	33	11544	46204	79686607
Gene mutation	26.13	25.81	11	11566	2675	79730136
Coombs direct test positive	26.09	25.81	7	11570	424	79732387
Abdominal discomfort	25.96	25.81	3	11574	250724	79482087
Leukaemia	25.92	25.81	14	11563	5911	79726900
Leukaemia cutis	25.90	25.81	6	11571	198	79732613

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	L01DB06	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS CYTOTOXIC ANTIBIOTICS AND RELATED SUBSTANCES Anthracyclines and related substances
FDA CS	M0028312	Anthracyclines
FDA MoA	N0000000176	Topoisomerase Inhibitors
FDA EPC	N0000175414	Anthracycline Topoisomerase Inhibitor
MeSH PA	D000903	Antibiotics, Antineoplastic
MeSH PA	D000970	Antineoplastic Agents
MeSH PA	D004791	Enzyme Inhibitors
MeSH PA	D059005	Topoisomerase II Inhibitors
MeSH PA	D059003	Topoisomerase Inhibitors

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

Disease	Relation	SNOMED_ID	DOID
Acute myeloid leukemia, disease	indication	91861009
Acute promyelocytic leukemia, FAB M3	indication	110004001
Pericarditis	contraindication	3238004	DOID:1787
Enterocolitis	contraindication	43752006
Conduction disorder of the heart	contraindication	44808001
Chronic heart failure	contraindication	48447003
Myocarditis	contraindication	50920009	DOID:820
Gastrointestinal perforation	contraindication	51875005
Acute infectious disease	contraindication	63171007
Cardiomyopathy	contraindication	85898001	DOID:0050700
Kidney disease	contraindication	90708001	DOID:557
Disease of liver	contraindication	235856003	DOID:409
Anemia	contraindication	271737000	DOID:2355
Pregnancy, function	contraindication	289908002
Bone marrow depression	contraindication	307762000
Breastfeeding (mother)	contraindication	413712001

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	8.01	acidic
pKa2	9.88	acidic
pKa3	11.6	acidic
pKa4	8.73	Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Bioact source	MoA source
DNA topoisomerase 2-alpha	Enzyme	P11388	TOP2A_HUMAN	INHIBITOR	WOMBAT-PK	CHEMBL
Multidrug resistance protein 1	Transporter	P08183	MDR1_HUMAN		WOMBAT-PK
Multidrug resistance-associated protein 1	Transporter	P33527	MRP1_HUMAN		WOMBAT-PK

External reference:

ID	Source
4019784	VUID
N0000147874	NUI
D01747	KEGG_DRUG
57852-57-0	SECONDARY_CAS_RN
4019569	VANDF
4019784	VANDF
C0020789	UMLSCUI
CHEBI:42068	CHEBI
DM5	PDB_CHEM_ID
CHEMBL1117	ChEMBL_ID
CHEMBL1200976	ChEMBL_ID
D015255	MESH_DESCRIPTOR_UI
DB01177	DRUGBANK_ID
7083	IUPHAR_LIGAND_ID
5174	INN_ID
ZRP63D75JW	UNII
42890	PUBCHEM_CID
5650	RXNORM
45101	MMSL
4865	MMSL
d00256	MMSL
003556	NDDF
004819	NDDF
108786002	SNOMEDCT_US
108788001	SNOMEDCT_US
372539000	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Idamycin PFS	HUMAN PRESCRIPTION DRUG LABEL	1	0013-2576	SOLUTION	1 mg	INTRAVENOUS	NDA	24 sections
Idamycin PFS	HUMAN PRESCRIPTION DRUG LABEL	1	0013-2576	SOLUTION	1 mg	INTRAVENOUS	NDA	24 sections
Idamycin PFS	HUMAN PRESCRIPTION DRUG LABEL	1	0013-2576	SOLUTION	1 mg	INTRAVENOUS	NDA	24 sections
Idamycin PFS	HUMAN PRESCRIPTION DRUG LABEL	1	0013-2586	SOLUTION	1 mg	INTRAVENOUS	NDA	24 sections
Idamycin PFS	HUMAN PRESCRIPTION DRUG LABEL	1	0013-2586	SOLUTION	1 mg	INTRAVENOUS	NDA	24 sections
Idamycin PFS	HUMAN PRESCRIPTION DRUG LABEL	1	0013-2586	SOLUTION	1 mg	INTRAVENOUS	NDA	24 sections
Idamycin PFS	HUMAN PRESCRIPTION DRUG LABEL	1	0013-2596	SOLUTION	1 mg	INTRAVENOUS	NDA	24 sections
Idamycin PFS	HUMAN PRESCRIPTION DRUG LABEL	1	0013-2596	SOLUTION	1 mg	INTRAVENOUS	NDA	24 sections
Idamycin PFS	HUMAN PRESCRIPTION DRUG LABEL	1	0013-2596	SOLUTION	1 mg	INTRAVENOUS	NDA	24 sections
Idarubicin Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9217	INJECTION, SOLUTION	1 mg	INTRAVENOUS	ANDA	23 sections
Idarubicin Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9217	INJECTION, SOLUTION	1 mg	INTRAVENOUS	ANDA	23 sections
Idarubicin Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9218	INJECTION, SOLUTION	1 mg	INTRAVENOUS	ANDA	23 sections
Idarubicin Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9218	INJECTION, SOLUTION	1 mg	INTRAVENOUS	ANDA	23 sections
Idarubicin Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9219	INJECTION, SOLUTION	1 mg	INTRAVENOUS	ANDA	23 sections
Idarubicin Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9219	INJECTION, SOLUTION	1 mg	INTRAVENOUS	ANDA	23 sections
Idarubicin Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9306	INJECTION, SOLUTION	1 mg	INTRAVENOUS	ANDA	23 sections
Idarubicin Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9307	INJECTION, SOLUTION	1 mg	INTRAVENOUS	ANDA	23 sections
Idarubicin Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9308	INJECTION, SOLUTION	1 mg	INTRAVENOUS	ANDA	23 sections
Idarubicin Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0703-4154	INJECTION, SOLUTION	1 mg	INTRAVENOUS	ANDA	23 sections
Idarubicin Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0703-4154	INJECTION, SOLUTION	1 mg	INTRAVENOUS	ANDA	23 sections
Idarubicin Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0703-4154	INJECTION, SOLUTION	1 mg	INTRAVENOUS	ANDA	23 sections
Idarubicin Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0703-4155	INJECTION, SOLUTION	1 mg	INTRAVENOUS	ANDA	23 sections
Idarubicin Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0703-4155	INJECTION, SOLUTION	1 mg	INTRAVENOUS	ANDA	23 sections
Idarubicin Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0703-4155	INJECTION, SOLUTION	1 mg	INTRAVENOUS	ANDA	23 sections
Idarubicin Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0703-4156	INJECTION, SOLUTION	1 mg	INTRAVENOUS	ANDA	23 sections
Idarubicin Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0703-4156	INJECTION, SOLUTION	1 mg	INTRAVENOUS	ANDA	23 sections
Idarubicin Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0703-4156	INJECTION, SOLUTION	1 mg	INTRAVENOUS	ANDA	23 sections