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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209028
Company: PRINSTON INC

Products on ANDA 209028

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 209028

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/06/2017	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/17/2026	SUPPL-8	Labeling-Patient Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
02/17/2026	SUPPL-5	Labeling-Container/Carton Labels, Labeling-Patient Package Insert, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/17/2026	SUPPL-4	Labeling-Container/Carton Labels, Labeling-Patient Package Insert		Label is not available on this site.
02/17/2026	SUPPL-2	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 209028

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
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
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
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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