Drugs@FDA: FDA-Approved Drugs

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

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 US PHARMS HOLDINGS I
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE 25MG;50MG TABLET;ORAL Prescription No AB 202870 ALEMBIC PHARMS LTD
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 PHARMS LTD
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 PHARMS LTD
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

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