Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 210207
Company: PIRAMAL HLTHCARE UK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription AB No No
CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET;ORAL Prescription AB No No
CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/01/2018 ORIG-1 Approval STANDARD

Label is not available on this site.

CINACALCET HYDROCHLORIDE

TABLET;ORAL; EQ 30MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription No AB 210570 ALKEM LABS LTD
CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription No AB 206125 AUROBINDO PHARMA LTD
CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription No AB 208915 CIPLA
CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription No AB 210548 LUPIN LTD
CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription No AB 203422 MYLAN
CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription No AB 210207 PIRAMAL HLTHCARE UK
CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription No AB 209226 STRIDES PHARMA
CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription No AB 207008 SUN PHARM
CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription No AB 204377 WATSON LABS TEVA
SENSIPAR CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription Yes AB 021688 AMGEN

TABLET;ORAL; EQ 60MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET;ORAL Prescription No AB 210570 ALKEM LABS LTD
CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET;ORAL Prescription No AB 206125 AUROBINDO PHARMA LTD
CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET;ORAL Prescription No AB 208915 CIPLA
CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET;ORAL Prescription No AB 210548 LUPIN LTD
CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET;ORAL Prescription No AB 203422 MYLAN
CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET;ORAL Prescription No AB 210207 PIRAMAL HLTHCARE UK
CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET;ORAL Prescription No AB 209226 STRIDES PHARMA
CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET;ORAL Prescription No AB 207008 SUN PHARM
CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET;ORAL Prescription No AB 204377 WATSON LABS TEVA
SENSIPAR CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET;ORAL Prescription Yes AB 021688 AMGEN

TABLET;ORAL; EQ 90MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET;ORAL Prescription No AB 210570 ALKEM LABS LTD
CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET;ORAL Prescription No AB 206125 AUROBINDO PHARMA LTD
CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET;ORAL Prescription No AB 208915 CIPLA
CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET;ORAL Prescription No AB 210548 LUPIN LTD
CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET;ORAL Prescription No AB 203422 MYLAN
CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET;ORAL Prescription No AB 210207 PIRAMAL HLTHCARE UK
CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET;ORAL Prescription No AB 209226 STRIDES PHARMA
CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET;ORAL Prescription No AB 207008 SUN PHARM
CINACALCET HYDROCHLORIDE CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET;ORAL Prescription No AB 204377 WATSON LABS TEVA
SENSIPAR CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET;ORAL Prescription Yes AB 021688 AMGEN

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