An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 021688
Company: AMGEN

Products on NDA 021688

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021688

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
12/05/2019	SUPPL-27	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021688s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021688Orig1s027ltr.pdf
03/29/2019	SUPPL-26	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021688s025s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021688Orig1s025, s026ltr.pdf
03/29/2019	SUPPL-25	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021688s025s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021688Orig1s025, s026ltr.pdf
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

Labels for NDA 021688

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/05/2019	SUPPL-27	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021688s027lbl.pdf
03/29/2019	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021688s025s026lbl.pdf
03/29/2019	SUPPL-25	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021688s025s026lbl.pdf
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

Therapeutic Equivalents for NDA 021688

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	211892	ACCORD HLTHCARE
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	213325	CHARTWELL RX
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	208368	DR REDDYS
CINACALCET HYDROCHLORIDE	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET;ORAL	Prescription	No	AB	209403	HETERO LABS LTD V
CINACALCET HYDROCHLORIDE	CINACALCET HYDROCHLORIDE	EQ 30MG BASE	TABLET;ORAL	Prescription	No	AB	210207	SLATE RUN PHARMA
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	211892	ACCORD HLTHCARE
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	213325	CHARTWELL RX
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	208368	DR REDDYS
CINACALCET HYDROCHLORIDE	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET;ORAL	Prescription	No	AB	209403	HETERO LABS LTD V
CINACALCET HYDROCHLORIDE	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET;ORAL	Prescription	No	AB	210207	SLATE RUN PHARMA
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	211892	ACCORD HLTHCARE
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	213325	CHARTWELL RX
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	208368	DR REDDYS
CINACALCET HYDROCHLORIDE	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET;ORAL	Prescription	No	AB	209403	HETERO LABS LTD V
CINACALCET HYDROCHLORIDE	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET;ORAL	Prescription	No	AB	210207	SLATE RUN PHARMA
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

Top