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

Abbreviated New Drug Application (ANDA): 076792
Company: MYLAN

Products on ANDA 076792

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE	25MG;50MG	TABLET;ORAL	Prescription	AB	No	No
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE	25MG;100MG	TABLET;ORAL	Prescription	AB	No	No
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE	50MG;100MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076792

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/20/2004	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76792ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/10/2023	SUPPL-35	Labeling-Package Insert		Label is not available on this site.
08/10/2023	SUPPL-27	Labeling-Package Insert		Label is not available on this site.
08/10/2023	SUPPL-18	Labeling-Package Insert		Label is not available on this site.
06/04/2010	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
10/21/2008	SUPPL-9	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076792

METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE

TABLET;ORAL; 25MG;50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LOPRESSOR HCT	HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE	25MG;50MG	TABLET;ORAL	Prescription	Yes	AB	018303	VALIDUS PHARMS
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE	25MG;50MG	TABLET;ORAL	Prescription	No	AB	202870	ALEMBIC
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE	25MG;50MG	TABLET;ORAL	Prescription	No	AB	076792	MYLAN
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE	25MG;50MG	TABLET;ORAL	Prescription	No	AB	090654	SUN PHARM INDS

TABLET;ORAL; 25MG;100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE	25MG;100MG	TABLET;ORAL	Prescription	No	AB	202870	ALEMBIC
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE	25MG;100MG	TABLET;ORAL	Prescription	No	AB	076792	MYLAN
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE	25MG;100MG	TABLET;ORAL	Prescription	No	AB	090654	SUN PHARM INDS

TABLET;ORAL; 50MG;100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE	50MG;100MG	TABLET;ORAL	Prescription	No	AB	202870	ALEMBIC
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE	50MG;100MG	TABLET;ORAL	Prescription	No	AB	076792	MYLAN
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE	50MG;100MG	TABLET;ORAL	Prescription	No	AB	090654	SUN PHARM INDS

Top