Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020838
Company: ANI PHARMS

• Other Important Information from FDA

Products on NDA 20838

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ATACAND	CANDESARTAN CILEXETIL	4MG	TABLET;ORAL	Prescription	AB	Yes	No
ATACAND	CANDESARTAN CILEXETIL	8MG	TABLET;ORAL	Prescription	AB	Yes	No
ATACAND	CANDESARTAN CILEXETIL	16MG	TABLET;ORAL	Prescription	AB	Yes	No
ATACAND	CANDESARTAN CILEXETIL	32MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Labels for NDA 020838

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/24/2020	SUPPL-41	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020838s041lbl.pdf
02/09/2016	SUPPL-39	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020838s039lbl.pdf
02/06/2015	SUPPL-36	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020838s036lbl.pdf
04/26/2013	SUPPL-38	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020838s038lbl.pdf
04/27/2012	SUPPL-35	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020838s035lbl.pdf
04/13/2012	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020838s032lbl.pdf
06/24/2011	SUPPL-33	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020838s033lbl.pdf
10/22/2009	SUPPL-31	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020838s031lbl.pdf
08/17/2006	SUPPL-26	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020838s026lbl.pdf
05/18/2005	SUPPL-22	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020838s022lbl.pdf
02/22/2005	SUPPL-24	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20838s024lbl.pdf
09/13/2002	SUPPL-15	Efficacy-Accelerated Approval Confirmatory Study	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20838s015lbl.pdf
06/04/1998	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20838lbl.pdf