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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203010
Company: ALEMBIC

Products on ANDA 203010

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203010

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/25/2014	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203010Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/12/2023	SUPPL-28	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
01/14/2022	SUPPL-19	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
11/06/2019	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
03/29/2016	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
03/29/2016	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
03/29/2016	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203010

TELMISARTAN AND HYDROCHLOROTHIAZIDE

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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