cinacalcet Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
	647	226256-56-0

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: cinacalcet mimpara cinacalcet hydrochloride sensipar AMG 073 AMG-073 KRN1493 cinacalcet HCl	Molecular weight: 357.42 Formula: C22H22F3N CLOGP: 6.35 LIPINSKI: 1 HAC: 1 HDO: 1 TPSA: 12.03 ALOGS: -6.81 ROTB: 7 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

cinacalcet
mimpara
cinacalcet hydrochloride
sensipar
AMG 073
AMG-073
KRN1493
cinacalcet HCl

Molecular weight: 357.42
Formula: C22H22F3N
CLOGP: 6.35
LIPINSKI: 1
HAC: 1
HDO: 1
TPSA: 12.03
ALOGS: -6.81
ROTB: 7

Status: OFP

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

Drug dosage:

Dose	Unit	Route
60	mg	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.10 mg/mL	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)	7.19 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	20 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	17.60 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	18.30 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.05 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	19.90 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
Oct. 22, 2004	EMA
March 8, 2004	FDA	AMGEN

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
Hospitalisation	8485.77	20.18	2554	24010	60831	46598667
Product dose omission issue	6904.18	20.18	2805	23759	165715	46493783
Laboratory test abnormal	6025.71	20.18	1572	24992	21275	46638223
Adverse drug reaction	1364.56	20.18	610	25954	43752	46615746
Blood parathyroid hormone increased	850.98	20.18	220	26344	2788	46656710
Intentional product misuse	846.49	20.18	449	26115	46679	46612819
Blood parathyroid hormone abnormal	470.29	20.18	85	26479	133	46659365
Hospice care	336.53	20.18	123	26441	5172	46654326
Arteriovenous fistula site complication	314.79	20.18	70	26494	437	46659061
Adverse event	283.82	20.18	199	26365	33985	46625513
Living in residential institution	254.15	20.18	56	26508	333	46659165
Calciphylaxis	242.82	20.18	80	26484	2455	46657043
Hypocalcaemia	215.49	20.18	153	26411	26632	46632866
Rehabilitation therapy	209.70	20.18	60	26504	1132	46658366
Blood calcium increased	193.91	20.18	92	26472	7495	46652003
Blood calcium decreased	178.00	20.18	111	26453	15562	46643936
Decreased appetite	174.97	20.18	358	26206	193478	46466020
Hypophagia	168.48	20.18	137	26427	29169	46630329
Transplant	161.45	20.18	43	26521	614	46658884
Death	160.67	20.18	486	26078	335062	46324436
Malaise	157.87	20.18	479	26085	330753	46328745
Abdominal discomfort	156.67	20.18	296	26268	150869	46508629
Nausea	153.82	20.18	782	25782	686672	45972826
Blood parathyroid hormone decreased	152.80	20.18	66	26498	4315	46655183
Blood calcium abnormal	149.89	20.18	43	26521	819	46658679
Parathyroidectomy	145.62	20.18	33	26531	227	46659271
Unevaluable investigation	122.40	20.18	21	26543	19	46659479
Renal transplant	120.23	20.18	40	26524	1265	46658233
Rheumatoid arthritis	115.47	20.18	5	26559	240210	46419288
Nephrogenic systemic fibrosis	110.23	20.18	54	26510	4718	46654780
Hypercalcaemia	109.73	20.18	93	26471	20953	46638545
Vomiting	107.72	20.18	525	26039	452269	46207229
Parathyroid tumour benign	102.91	20.18	30	26534	606	46658892
Fatigue	88.86	20.18	131	26433	608566	46050932
Brown tumour	85.35	20.18	16	26548	34	46659464
Blood phosphorus increased	77.62	20.18	36	26528	2783	46656715
Gastrointestinal tube insertion	74.73	20.18	27	26537	1096	46658402
Pyrexia	72.00	20.18	56	26508	348746	46310752
Arthralgia	70.97	20.18	62	26502	364541	46294957
Peritonitis bacterial	70.86	20.18	50	26514	8603	46650895
Hungry bone syndrome	69.87	20.18	12	26552	11	46659487
Mastication disorder	69.40	20.18	30	26534	1964	46657534
Skin induration	66.74	20.18	33	26531	2941	46656557
Blood phosphorus abnormal	66.60	20.18	16	26548	146	46659352
Dialysis	63.88	20.18	50	26514	10066	46649432
Condition aggravated	54.89	20.18	36	26528	245016	46414482
Abdominal pain upper	51.83	20.18	191	26373	145114	46514384
Pain	50.67	20.18	124	26440	476824	46182674
Neutropenia	50.60	20.18	10	26554	143194	46516304
Gastrostomy	50.49	20.18	17	26547	558	46658940
Toxicity to various agents	50.35	20.18	29	26535	211737	46447761
Arteriovenous fistula occlusion	46.60	20.18	14	26550	315	46659183
Sinusitis	45.98	20.18	9	26555	129759	46529739
Skin hypertrophy	45.64	20.18	26	26538	3085	46656413
Drug ineffective	45.01	20.18	216	26348	677622	45981876
Injection site pain	43.52	20.18	5	26559	107147	46552351
Parathyroid disorder	43.36	20.18	15	26549	535	46658963
Drug hypersensitivity	43.24	20.18	45	26519	243780	46415718
Skin fibrosis	42.26	20.18	17	26547	928	46658570
Joint swelling	42.01	20.18	21	26543	166052	46493446
Skin tightness	40.26	20.18	26	26538	3867	46655631
Unevaluable event	39.97	20.18	84	26480	46091	46613407
Hyperparathyroidism	39.85	20.18	22	26542	2457	46657041
Surgery	38.29	20.18	63	26501	28722	46630776
Hyperphosphataemia	38.28	20.18	19	26545	1707	46657791
Enteral nutrition	37.98	20.18	8	26556	37	46659461
White blood cell count decreased	37.28	20.18	9	26555	112222	46547276
Blue toe syndrome	37.22	20.18	12	26552	343	46659155
Febrile neutropenia	37.00	20.18	5	26559	94622	46564876
Treatment failure	36.21	20.18	5	26559	93082	46566416
Chronic kidney disease-mineral and bone disorder	36.14	20.18	11	26553	259	46659239
Gastrointestinal disorder	35.84	20.18	94	26470	59482	46600016
Alanine aminotransferase increased	33.82	20.18	5	26559	88446	46571052
Pelvic deformity	33.03	20.18	10	26554	231	46659267
Hepatic enzyme increased	32.76	20.18	4	26560	81783	46577715
Thyroid operation	32.11	20.18	9	26555	157	46659341
Headache	31.90	20.18	152	26412	478200	46181298
Fluid overload	31.55	20.18	56	26508	27129	46632369
Arteriovenous fistula site infection	30.78	20.18	7	26557	49	46659449
Neuropathy peripheral	30.76	20.18	7	26557	90886	46568612
Joint contracture	28.84	20.18	15	26549	1487	46658011
End stage renal disease	28.61	20.18	25	26539	5861	46653637
Stomatitis	28.20	20.18	3	26561	68294	46591204
Dyspnoea	27.69	20.18	176	26388	515372	46144126
Weight increased	27.32	20.18	32	26532	164441	46495057
Shunt stenosis	26.92	20.18	9	26555	289	46659209
Aspartate aminotransferase increased	26.75	20.18	6	26558	78694	46580804
Malignant neoplasm progression	26.43	20.18	3	26561	64923	46594575
Platelet count decreased	26.27	20.18	12	26552	100012	46559486
Dysphagia	26.17	20.18	100	26464	77212	46582286
Peritonitis	25.77	20.18	44	26520	20670	46638828
Upper respiratory tract infection	25.72	20.18	3	26561	63553	46595945
Cardiac operation	25.60	20.18	17	26547	2649	46656849
Wrong technique in product usage process	25.07	20.18	78	26486	54344	46605154
Rash	24.48	20.18	112	26452	356400	46303098
Arthropathy	24.12	20.18	9	26555	84691	46574807
Drug interaction	23.75	20.18	50	26514	203044	46456454
Hyperparathyroidism tertiary	23.65	20.18	4	26560	3	46659495
Cough	23.47	20.18	61	26503	230188	46429310
Intravascular haemolysis	23.44	20.18	8	26556	274	46659224
Treatment noncompliance	23.33	20.18	52	26512	29679	46629819
Therapeutic product effect decreased	23.15	20.18	9	26555	82592	46576906
Parathyroid tumour malignant	23.12	20.18	4	26560	4	46659494
Shunt occlusion	23.03	20.18	9	26555	455	46659043
Migraine	22.51	20.18	6	26558	70020	46589478
Hyperparathyroidism secondary	22.34	20.18	12	26552	1270	46658228
Contusion	22.20	20.18	11	26553	87476	46572022
Product use in unapproved indication	21.95	20.18	12	26552	90261	46569237
Arteriovenous fistula site haemorrhage	21.61	20.18	7	26557	203	46659295
Medical procedure	21.58	20.18	7	26557	204	46659294
Gastric disorder	21.29	20.18	47	26517	26658	46632840
Adjusted calcium decreased	21.23	20.18	6	26558	108	46659390
Cerebrovascular accident	20.91	20.18	113	26451	100926	46558572
Fibrosis	20.76	20.18	17	26547	3647	46655851
Acute kidney injury	20.74	20.18	67	26497	235788	46423710
Fall	20.50	20.18	107	26457	328990	46330508
Wheezing	20.45	20.18	3	26561	53383	46606115

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
Product dose omission issue	7649.61	20.64	2726	18889	88905	29841958
Hospitalisation	6899.06	20.64	2118	19497	42201	29888662
Laboratory test abnormal	5920.74	20.64	1538	20077	15904	29914959
Adverse drug reaction	1066.51	20.64	454	21161	22691	29908172
Intentional product misuse	731.48	20.64	398	21217	34269	29896594
Blood parathyroid hormone increased	644.34	20.64	158	21457	1220	29929643
Blood parathyroid hormone abnormal	461.34	20.64	84	21531	93	29930770
Arteriovenous fistula site complication	363.53	20.64	80	21535	356	29930507
Adverse event	221.61	20.64	138	21477	15203	29915660
Transplant	216.97	20.64	57	21558	595	29930268
Hospice care	203.37	20.64	87	21528	4365	29926498
Blood parathyroid hormone decreased	198.30	20.64	50	21565	437	29930426
Blood calcium increased	194.62	20.64	76	21539	3011	29927852
Parathyroidectomy	191.14	20.64	36	21579	55	29930808
Living in residential institution	176.38	20.64	39	21576	178	29930685
Abdominal discomfort	161.00	20.64	187	21428	48604	29882259
Blood calcium abnormal	143.41	20.64	38	21577	411	29930452
Blood calcium decreased	143.08	20.64	88	21527	9474	29921389
Hypocalcaemia	137.76	20.64	118	21497	21258	29909605
Nausea	136.41	20.64	496	21119	296461	29634402
Rehabilitation therapy	127.86	20.64	37	21578	566	29930297
Blood phosphorus increased	125.79	20.64	53	21562	2558	29928305
Hypophagia	121.88	20.64	112	21503	22124	29908739
Calciphylaxis	109.90	20.64	38	21577	1060	29929803
Vomiting	109.10	20.64	377	21238	219441	29711422
Renal transplant	102.13	20.64	41	21574	1747	29929116
Unevaluable investigation	101.33	20.64	18	21597	15	29930848
Acute kidney injury	99.23	20.64	37	21578	273805	29657058
Hypercalcaemia	95.13	20.64	76	21539	12419	29918444
Toxicity to various agents	85.45	20.64	13	21602	177170	29753693
Abdominal pain upper	77.95	20.64	152	21463	62399	29868464
Pyrexia	77.18	20.64	60	21555	294429	29636434
Malaise	74.65	20.64	277	21338	166685	29764178
Parathyroid tumour benign	73.57	20.64	17	21598	98	29930765
Parathyroid disorder	66.49	20.64	14	21601	48	29930815
Death	63.92	20.64	458	21157	356825	29574038
Surgery	59.06	20.64	56	21559	11495	29919368
Gastrointestinal tube insertion	55.10	20.64	24	21591	1257	29929606
Neutropenia	54.36	20.64	13	21602	128527	29802336
Hyperparathyroidism secondary	50.22	20.64	22	21593	1168	29929695
Gastrointestinal disorder	48.71	20.64	79	21536	28058	29902805
Decreased appetite	48.27	20.64	225	21390	149685	29781178
Mastication disorder	47.83	20.64	21	21594	1121	29929742
Gastrostomy	45.95	20.64	18	21597	718	29930145
Nephrogenic systemic fibrosis	45.32	20.64	32	21583	4339	29926524
Hyperparathyroidism	44.79	20.64	19	21596	932	29929931
Fatigue	44.61	20.64	104	21511	320569	29610294
Adjusted calcium decreased	43.64	20.64	7	21608	0	29930863
Hungry bone syndrome	43.37	20.64	10	21605	57	29930806
Drug interaction	41.33	20.64	50	21565	199518	29731345
Shunt occlusion	41.24	20.64	16	21599	622	29930241
Gastric disorder	40.86	20.64	44	21571	10499	29920364
Blood phosphorus abnormal	39.80	20.64	11	21604	141	29930722
Hyperphosphataemia	39.52	20.64	23	21592	2236	29928627
Dialysis	39.33	20.64	44	21571	10952	29919911
Unevaluable event	38.05	20.64	76	21539	31709	29899154
Platelet count decreased	37.22	20.64	15	21600	106114	29824749
Treatment noncompliance	35.93	20.64	65	21550	25188	29905675
Dyspnoea	34.68	20.64	124	21491	333171	29597692
Peritonitis bacterial	33.17	20.64	41	21574	11337	29919526
Overdose	32.86	20.64	10	21605	84327	29846536
Condition aggravated	32.45	20.64	31	21584	137835	29793028
Leg amputation	32.26	20.64	20	21595	2181	29928682
Confusional state	32.11	20.64	30	21585	134804	29796059
Hyperparathyroidism tertiary	31.17	20.64	5	21610	0	29930863
White blood cell count decreased	30.87	20.64	11	21604	83936	29846927
Appetite disorder	30.85	20.64	18	21597	1758	29929105
Alanine aminotransferase increased	30.43	20.64	8	21607	74268	29856595
Shunt stenosis	30.00	20.64	11	21604	365	29930498
Hyponatraemia	30.00	20.64	6	21609	67196	29863667
Dehydration	29.99	20.64	27	21588	123512	29807351
Haemoglobin increased	29.52	20.64	21	21594	2881	29927982
Anaemia	29.22	20.64	67	21548	207925	29722938
Pulmonary embolism	29.14	20.64	10	21605	78125	29852738
Disease progression	28.47	20.64	11	21604	79863	29851000
Skin induration	27.16	20.64	18	21597	2201	29928662
Thyroid operation	26.80	20.64	5	21610	7	29930856
Rhabdomyolysis	25.76	20.64	7	21608	63573	29867290
Thrombocytopenia	25.61	20.64	37	21578	137007	29793856
Plasma cell myeloma	25.54	20.64	4	21611	53458	29877405
Pancytopenia	25.29	20.64	15	21600	85037	29845826
Brown tumour	24.94	20.64	4	21611	0	29930863
Parathyroid tumour malignant	24.94	20.64	4	21611	0	29930863
Parathyroid hyperplasia	24.94	20.64	4	21611	0	29930863
Neuropathy peripheral	24.63	20.64	10	21605	70465	29860398
Aspartate aminotransferase increased	23.85	20.64	8	21607	63414	29867449
Wrong technique in product usage process	23.41	20.64	62	21553	31093	29899770
Product use in unapproved indication	23.35	20.64	12	21603	73681	29857182
Calcinosis	22.99	20.64	11	21604	717	29930146
Tachycardia	21.93	20.64	13	21602	73726	29857137
Weight decreased	20.86	20.64	49	21566	150872	29779991

Pharmacologic Action:

Source	Code	Description
ATC	H05BX01	SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS CALCIUM HOMEOSTASIS ANTI-PARATHYROID AGENTS Other anti-parathyroid agents
FDA MoA	N0000020081	Increased Calcium-sensing Receptor Sensitivity
MeSH PA	D057966	Calcimimetic Agents
MeSH PA	D000077264	Calcium-Regulating Hormones and Agents
MeSH PA	D006727	Hormone Antagonists
FDA EPC	N0000175902	Calcium-sensing Receptor Agonist
CHEBI has role	CHEBI:48525	calcimimetics
CHEBI has role	CHEBI:50183	cytochrome p450 inhibitor

Drug Use (View source of the data)

Disease	Relation	SNOMED_ID	DOID
Hypercalcemia due to Primary Hyperparathyroidism	indication
Hyperparathyroidism Secondary to Chronic Renal Failure with Dialysis	indication
Parathyroid Carcinoma with Hypercalcemia	indication
Hypophosphatemia	contraindication	4996001
Hypocalcemia	contraindication	5291005
Low blood pressure	contraindication	45007003
Chronic heart failure	contraindication	48447003
Seizure disorder	contraindication	128613002
Disease of liver	contraindication	235856003	DOID:409
Adynamic bone disease	contraindication	236552002

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	8.69	Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
EQ 30MG BASE	SENSIPAR	AMGEN	N021688	March 8, 2004	RX	TABLET	ORAL	Nov. 21, 2021	TREATMENT OF HYPERCALCEMIA IN ADULT PATIENTS WITH PRIMARY HYPERPARATHYROIDISM FOR WHOM PARATHYROIDECTOMY WOULD BE INDICATED ON THE BASIS OF SERUM CALCIUM LEVELS, BUT WHO ARE UNULLBLE TO UNDERGO PARATHYROIDECTOMY.
EQ 60MG BASE	SENSIPAR	AMGEN	N021688	March 8, 2004	RX	TABLET	ORAL	Nov. 21, 2021	TREATMENT OF HYPERCALCEMIA IN ADULT PATIENTS WITH PRIMARY HYPERPARATHYROIDISM FOR WHOM PARATHYROIDECTOMY WOULD BE INDICATED ON THE BASIS OF SERUM CALCIUM LEVELS, BUT WHO ARE UNULLBLE TO UNDERGO PARATHYROIDECTOMY.
EQ 90MG BASE	SENSIPAR	AMGEN	N021688	March 8, 2004	RX	TABLET	ORAL	Nov. 21, 2021	TREATMENT OF HYPERCALCEMIA IN ADULT PATIENTS WITH PRIMARY HYPERPARATHYROIDISM FOR WHOM PARATHYROIDECTOMY WOULD BE INDICATED ON THE BASIS OF SERUM CALCIUM LEVELS, BUT WHO ARE UNULLBLE TO UNDERGO PARATHYROIDECTOMY.

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Extracellular calcium-sensing receptor	GPCR	P41180	CASR_HUMAN	POSITIVE ALLOSTERIC MODULATOR	EC50	7.70		CHEMBL	CHEMBL
Glycine receptor subunit alpha-1	Ion channel	P23415	GLRA1_HUMAN		EC50	6.49		CHEMBL

External reference:

ID	Source
4021430	VUID
N0000148841	NUI
D03504	KEGG_DRUG
364782-34-3	SECONDARY_CAS_RN
4021430	VANDF
C1260201	UMLSCUI
CHEBI:48390	CHEBI
CHEMBL1201284	ChEMBL_ID
CHEMBL1200776	ChEMBL_ID
DB01012	DRUGBANK_ID
D000069449	MESH_DESCRIPTOR_UI
156418	PUBCHEM_CID
3308	IUPHAR_LIGAND_ID
8287	INN_ID
UAZ6V7728S	UNII
384379	RXNORM
18133	MMSL
303128	MMSL
49840	MMSL
d05218	MMSL
008595	NDDF
008596	NDDF
409391006	SNOMEDCT_US
409392004	SNOMEDCT_US
426512007	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Cinacalcet	HUMAN PRESCRIPTION DRUG LABEL	1	0904-7067	TABLET, FILM COATED	30 mg	ORAL	ANDA	25 sections
Cinacalcet	Human Prescription Drug Label	1	16714-078	TABLET, FILM COATED	30 mg	ORAL	ANDA	27 sections
Cinacalcet	Human Prescription Drug Label	1	16714-079	TABLET, FILM COATED	60 mg	ORAL	ANDA	27 sections
Cinacalcet	Human Prescription Drug Label	1	16714-080	TABLET, FILM COATED	90 mg	ORAL	ANDA	27 sections
CINULLCALCET	HUMAN PRESCRIPTION DRUG LABEL	1	16729-440	TABLET, FILM COATED	30 mg	ORAL	ANDA	25 sections
CINULLCALCET	HUMAN PRESCRIPTION DRUG LABEL	1	16729-441	TABLET, FILM COATED	60 mg	ORAL	ANDA	25 sections
CINULLCALCET	HUMAN PRESCRIPTION DRUG LABEL	1	16729-442	TABLET, FILM COATED	90 mg	ORAL	ANDA	25 sections
Cinacalcet	Human Prescription Drug Label	1	31722-103	TABLET, FILM COATED	30 mg	ORAL	ANDA	29 sections
Cinacalcet	Human Prescription Drug Label	1	31722-104	TABLET, FILM COATED	60 mg	ORAL	ANDA	29 sections
Cinacalcet	Human Prescription Drug Label	1	31722-105	TABLET, FILM COATED	90 mg	ORAL	ANDA	29 sections
Cinacalcet	HUMAN PRESCRIPTION DRUG LABEL	1	42543-961	TABLET, FILM COATED	30 mg	ORAL	ANDA	23 sections
Cinacalcet	HUMAN PRESCRIPTION DRUG LABEL	1	42543-962	TABLET, FILM COATED	60 mg	ORAL	ANDA	23 sections
Cinacalcet	HUMAN PRESCRIPTION DRUG LABEL	1	42543-963	TABLET, FILM COATED	90 mg	ORAL	ANDA	23 sections
Cinacalcet	HUMAN PRESCRIPTION DRUG LABEL	1	43598-367	TABLET	30 mg	ORAL	ANDA	24 sections
Cinacalcet	HUMAN PRESCRIPTION DRUG LABEL	1	43598-368	TABLET	60 mg	ORAL	ANDA	24 sections
Cinacalcet	HUMAN PRESCRIPTION DRUG LABEL	1	43598-369	TABLET	90 mg	ORAL	ANDA	24 sections
Cinacalcet	Human Prescription Drug Label	1	47335-379	TABLET, FILM COATED	30 mg	ORAL	ANDA	27 sections
Cinacalcet	Human Prescription Drug Label	1	47335-380	TABLET, FILM COATED	60 mg	ORAL	ANDA	27 sections
Cinacalcet	Human Prescription Drug Label	1	47335-600	TABLET, FILM COATED	90 mg	ORAL	ANDA	27 sections
Sensipar	HUMAN PRESCRIPTION DRUG LABEL	1	50090-3529	TABLET, COATED	30 mg	ORAL	NDA	28 sections
Sensipar	HUMAN PRESCRIPTION DRUG LABEL	1	50090-4470	TABLET, COATED	30 mg	ORAL	NDA	26 sections
Cinacalcet	HUMAN PRESCRIPTION DRUG LABEL	1	51407-295	TABLET, FILM COATED	30 mg	ORAL	ANDA	23 sections
Cinacalcet	HUMAN PRESCRIPTION DRUG LABEL	1	51407-296	TABLET, FILM COATED	60 mg	ORAL	ANDA	23 sections
Cinacalcet	HUMAN PRESCRIPTION DRUG LABEL	1	51407-297	TABLET, FILM COATED	90 mg	ORAL	ANDA	23 sections
Sensipar	HUMAN PRESCRIPTION DRUG LABEL	1	53808-0577	TABLET, COATED	30 mg	ORAL	NDA	26 sections
Sensipar	HUMAN PRESCRIPTION DRUG LABEL	1	53808-0578	TABLET, COATED	60 mg	ORAL	NDA	26 sections
Sensipar	HUMAN PRESCRIPTION DRUG LABEL	1	54868-5616	TABLET, COATED	30 mg	ORAL	NDA	22 sections
Sensipar	HUMAN PRESCRIPTION DRUG LABEL	1	55513-073	TABLET, COATED	30 mg	ORAL	NDA	27 sections
Sensipar	HUMAN PRESCRIPTION DRUG LABEL	1	55513-074	TABLET, COATED	60 mg	ORAL	NDA	27 sections
Sensipar	HUMAN PRESCRIPTION DRUG LABEL	1	55513-075	TABLET, COATED	90 mg	ORAL	NDA	27 sections