Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021688
Company: AMGEN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SENSIPAR CINACALCET HYDROCHLORIDE EQ 30MG BASE TABLET;ORAL Prescription AB Yes No
SENSIPAR CINACALCET HYDROCHLORIDE EQ 60MG BASE TABLET;ORAL Prescription AB Yes No
SENSIPAR CINACALCET HYDROCHLORIDE EQ 90MG BASE TABLET;ORAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/08/2004 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21688_sensipar_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21688ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-688_Sensipar.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/15/2017 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021688s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021688Orig1s024ltr.pdf
05/23/2017 SUPPL-23 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021688s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021688Orig1s023ltr.pdf
11/21/2014 SUPPL-22 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021688s20_21_22lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021688Orig1s020,s021,s022ltr.pdf
11/21/2014 SUPPL-21 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021688s20_21_22lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021688Orig1s020,s021,s022ltr.pdf
11/21/2014 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021688s20_21_22lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021688Orig1s020,s021,s022ltr.pdf
08/01/2011 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021688s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021688s017ltr.pdf
02/25/2011 SUPPL-15 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021688s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021688s015ltr.pdf
11/12/2009 SUPPL-13 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021688s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021688s013ltr.pdf
12/19/2008 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021688s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021688s011ltr.pdf
05/02/2008 SUPPL-9 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021688s009ltr.pdf
02/28/2008 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021688s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021688s008ltr.pdf
10/04/2007 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021688s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021688s006ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/23/2017 SUPPL-23 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021688s023lbl.pdf
05/15/2017 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021688s024lbl.pdf
11/21/2014 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021688s20_21_22lbl.pdf
11/21/2014 SUPPL-21 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021688s20_21_22lbl.pdf
11/21/2014 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021688s20_21_22lbl.pdf
08/01/2011 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021688s017lbl.pdf
02/25/2011 SUPPL-15 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021688s015lbl.pdf
11/12/2009 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021688s013lbl.pdf
12/19/2008 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021688s011lbl.pdf
02/28/2008 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021688s008lbl.pdf
10/04/2007 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021688s006lbl.pdf
03/08/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21688_sensipar_lbl.pdf

SENSIPAR

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 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 203422 MYLAN PHARMS INC
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 PHARMA GLOBAL
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 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 203422 MYLAN PHARMS INC
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 PHARMA GLOBAL
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 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 203422 MYLAN PHARMS INC
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 PHARMA GLOBAL
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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