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

Stem definitionDrug idCAS RN
647 226256-56-0

Description:

MoleculeDescription

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:

DoseUnitRoute
60 mg O

ADMET properties:

PropertyValueReference
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 ┬ÁM/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:

DateAgencyCompanyOrphan
Oct. 22, 2004 EMA
March 8, 2004 FDA AMGEN

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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:

SourceCodeDescription
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)

DiseaseRelationSNOMED_IDDOID
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 levelDissociation constantType (acidic/basic)
pKa1 8.69 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
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:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Extracellular calcium-sensing receptor GPCR POSITIVE ALLOSTERIC MODULATOR EC50 7.70 CHEMBL CHEMBL
Glycine receptor subunit alpha-1 Ion channel EC50 6.49 CHEMBL

External reference:

IDSource
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:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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