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): 021093
Company: ANI PHARMS

Other Important Information from FDA

Products on NDA 021093

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ATACAND HCT	CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE	16MG;12.5MG	TABLET;ORAL	Prescription	AB	Yes	No
ATACAND HCT	CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE	32MG;12.5MG	TABLET;ORAL	Prescription	AB	Yes	No
ATACAND HCT	CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE	32MG;25MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021093

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/05/2000	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21093lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21093ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-093_AtacandHCT.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/20/2020	SUPPL-21	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021093s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021093Orig1s021ltr.pdf
02/09/2016	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021093s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021093Orig1s019ltr.pdf
04/26/2013	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021093s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021093Orig1s018ltr.pdf
02/09/2015	SUPPL-16	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021093s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021093Orig1s016ltr.pdf
03/29/2012	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021093s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021093s015ltr.pdf
06/14/2011	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021093s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021093s013ltr.pdf
03/11/2011	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021093s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019888s049,021093s012ltr.pdf
05/16/2008	SUPPL-8	Labeling-Package Insert, Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021093s008ltr.pdf
08/17/2006	SUPPL-6	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021093s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021093s006LTR.pdf
12/16/2004	SUPPL-4	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21093s004ltr.pdf
07/03/2002	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
11/28/2001	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 021093

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/20/2020	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021093s021lbl.pdf
02/09/2016	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021093s019lbl.pdf
02/09/2015	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021093s016lbl.pdf
04/26/2013	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021093s018lbl.pdf
03/29/2012	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021093s015lbl.pdf
06/14/2011	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021093s013lbl.pdf
03/11/2011	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021093s012lbl.pdf
08/17/2006	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021093s006lbl.pdf
09/05/2000	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21093lbl.pdf

Therapeutic Equivalents for NDA 021093

ATACAND HCT

TABLET;ORAL; 16MG;12.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ATACAND HCT	CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE	16MG;12.5MG	TABLET;ORAL	Prescription	Yes	AB	021093	ANI PHARMS
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE	16MG;12.5MG	TABLET;ORAL	Prescription	No	AB	202965	DR REDDYS LABS LTD
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE	16MG;12.5MG	TABLET;ORAL	Prescription	No	AB	204100	MACLEODS PHARMS LTD
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE	16MG;12.5MG	TABLET;ORAL	Prescription	No	AB	090704	MYLAN
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE	16MG;12.5MG	TABLET;ORAL	Prescription	No	AB	207455	PRINSTON INC
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE	16MG;12.5MG	TABLET;ORAL	Prescription	No	AB	203466	ZYDUS LIFESCIENCES

TABLET;ORAL; 32MG;12.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ATACAND HCT	CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE	32MG;12.5MG	TABLET;ORAL	Prescription	Yes	AB	021093	ANI PHARMS
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE	32MG;12.5MG	TABLET;ORAL	Prescription	No	AB	202965	DR REDDYS LABS LTD
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE	32MG;12.5MG	TABLET;ORAL	Prescription	No	AB	204100	MACLEODS PHARMS LTD
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE	32MG;12.5MG	TABLET;ORAL	Prescription	No	AB	090704	MYLAN
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE	32MG;12.5MG	TABLET;ORAL	Prescription	No	AB	207455	PRINSTON INC
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE	32MG;12.5MG	TABLET;ORAL	Prescription	No	AB	203466	ZYDUS LIFESCIENCES

TABLET;ORAL; 32MG;25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ATACAND HCT	CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE	32MG;25MG	TABLET;ORAL	Prescription	Yes	AB	021093	ANI PHARMS
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE	32MG;25MG	TABLET;ORAL	Prescription	No	AB	202965	DR REDDYS LABS LTD
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE	32MG;25MG	TABLET;ORAL	Prescription	No	AB	204100	MACLEODS PHARMS LTD
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE	32MG;25MG	TABLET;ORAL	Prescription	No	AB	090704	MYLAN
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE	32MG;25MG	TABLET;ORAL	Prescription	No	AB	207455	PRINSTON INC
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE	32MG;25MG	TABLET;ORAL	Prescription	No	AB	203466	ZYDUS LIFESCIENCES

Top