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	Discontinued	None	Yes	No
SENSIPAR	CINACALCET HYDROCHLORIDE	EQ 60MG BASE	TABLET;ORAL	Discontinued	None	Yes	No
SENSIPAR	CINACALCET HYDROCHLORIDE	EQ 90MG BASE	TABLET;ORAL	Discontinued	None	Yes	No

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.html

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

Top