Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 021688
Company: AMGEN

Products on NDA 21688

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

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