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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021162
Company: BOEHRINGER INGELHEIM

Other Important Information from FDA

Products on NDA 021162

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MICARDIS HCT	HYDROCHLOROTHIAZIDE; TELMISARTAN	12.5MG;40MG	TABLET;ORAL	Prescription	AB	Yes	No
MICARDIS HCT	HYDROCHLOROTHIAZIDE; TELMISARTAN	12.5MG;80MG	TABLET;ORAL	Prescription	AB	Yes	No
MICARDIS HCT	HYDROCHLOROTHIAZIDE; TELMISARTAN	25MG;80MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021162

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/17/2000	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21162lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21162ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-162_Micards.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/19/2022	SUPPL-47	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021162s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021162Orig1s047ltr.pdf
08/20/2020	SUPPL-45	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021162s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021162Orig1s045ltr.pdf
02/01/2018	SUPPL-40	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021162s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021162Orig1s040ltr.pdf
12/12/2014	SUPPL-37	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021162s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021162Orig1s037ltr.pdf
10/24/2012	SUPPL-35	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021162s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021162Orig1s035ltr.pdf
01/19/2012	SUPPL-34	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021162s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021162s034ltr.pdf
01/12/2016	SUPPL-32	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021162s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021162Orig1s032ltr.pdf
05/12/2011	SUPPL-31	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021162s029s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021162s029,s031ltr.pdf
01/20/2012	SUPPL-30	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021162s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021162s030ltr.pdf
05/12/2011	SUPPL-29	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021162s029s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021162s029,s031ltr.pdf
08/11/2009	SUPPL-20	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021162s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021162s019,s020ltr.pdf
08/11/2009	SUPPL-19	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021162s019s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021162s019,s020ltr.pdf
02/27/2007	SUPPL-16	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021162s016ltr.pdf
09/02/2005	SUPPL-8	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021162s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021162s008ltr.pdf
04/19/2004	SUPPL-5	Manufacturing (CMC)	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21162scm005ltr.pdf

Labels for NDA 021162

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/19/2022	SUPPL-47	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021162s047lbl.pdf
08/20/2020	SUPPL-45	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021162s045lbl.pdf
02/01/2018	SUPPL-40	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021162s040lbl.pdf
01/12/2016	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021162s032lbl.pdf
12/12/2014	SUPPL-37	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021162s037lbl.pdf
10/24/2012	SUPPL-35	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021162s035lbl.pdf
01/20/2012	SUPPL-30	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021162s030lbl.pdf
01/19/2012	SUPPL-34	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021162s034lbl.pdf
05/12/2011	SUPPL-31	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021162s029s031lbl.pdf
05/12/2011	SUPPL-29	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021162s029s031lbl.pdf
08/11/2009	SUPPL-20	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021162s019s020lbl.pdf
08/11/2009	SUPPL-19	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021162s019s020lbl.pdf
09/02/2005	SUPPL-8	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021162s008lbl.pdf
11/17/2000	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21162lbl.pdf

Therapeutic Equivalents for NDA 021162

MICARDIS HCT

TABLET;ORAL; 12.5MG;40MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MICARDIS HCT	HYDROCHLOROTHIAZIDE; TELMISARTAN	12.5MG;40MG	TABLET;ORAL	Prescription	Yes	AB	021162	BOEHRINGER INGELHEIM
TELMISARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TELMISARTAN	12.5MG;40MG	TABLET;ORAL	Prescription	No	AB	203010	ALEMBIC
TELMISARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TELMISARTAN	12.5MG;40MG	TABLET;ORAL	Prescription	No	AB	208727	AUROBINDO PHARMA
TELMISARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TELMISARTAN	12.5MG;40MG	TABLET;ORAL	Prescription	No	AB	202544	GLENMARK PHARMS LTD
TELMISARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TELMISARTAN	12.5MG;40MG	TABLET;ORAL	Prescription	No	AB	091351	LUPIN LTD
TELMISARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TELMISARTAN	12.5MG;40MG	TABLET;ORAL	Prescription	No	AB	209028	PRINSTON INC
TELMISARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TELMISARTAN	12.5MG;40MG	TABLET;ORAL	Prescription	No	AB	204221	ZYDUS PHARMS

TABLET;ORAL; 12.5MG;80MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MICARDIS HCT	HYDROCHLOROTHIAZIDE; TELMISARTAN	12.5MG;80MG	TABLET;ORAL	Prescription	Yes	AB	021162	BOEHRINGER INGELHEIM
TELMISARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TELMISARTAN	12.5MG;80MG	TABLET;ORAL	Prescription	No	AB	203010	ALEMBIC
TELMISARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TELMISARTAN	12.5MG;80MG	TABLET;ORAL	Prescription	No	AB	208727	AUROBINDO PHARMA
TELMISARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TELMISARTAN	12.5MG;80MG	TABLET;ORAL	Prescription	No	AB	202544	GLENMARK PHARMS LTD
TELMISARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TELMISARTAN	12.5MG;80MG	TABLET;ORAL	Prescription	No	AB	091351	LUPIN LTD
TELMISARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TELMISARTAN	12.5MG;80MG	TABLET;ORAL	Prescription	No	AB	209028	PRINSTON INC
TELMISARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TELMISARTAN	12.5MG;80MG	TABLET;ORAL	Prescription	No	AB	204221	ZYDUS PHARMS

TABLET;ORAL; 25MG;80MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MICARDIS HCT	HYDROCHLOROTHIAZIDE; TELMISARTAN	25MG;80MG	TABLET;ORAL	Prescription	Yes	AB	021162	BOEHRINGER INGELHEIM
TELMISARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TELMISARTAN	25MG;80MG	TABLET;ORAL	Prescription	No	AB	203010	ALEMBIC
TELMISARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TELMISARTAN	25MG;80MG	TABLET;ORAL	Prescription	No	AB	208727	AUROBINDO PHARMA
TELMISARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TELMISARTAN	25MG;80MG	TABLET;ORAL	Prescription	No	AB	202544	GLENMARK PHARMS LTD
TELMISARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TELMISARTAN	25MG;80MG	TABLET;ORAL	Prescription	No	AB	091351	LUPIN LTD
TELMISARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TELMISARTAN	25MG;80MG	TABLET;ORAL	Prescription	No	AB	209028	PRINSTON INC
TELMISARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; TELMISARTAN	25MG;80MG	TABLET;ORAL	Prescription	No	AB	204221	ZYDUS PHARMS

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