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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090654
Company: SUN PHARM INDS

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 Discontinued None No No
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE 25MG;100MG TABLET;ORAL Discontinued None No No
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE 50MG;100MG TABLET;ORAL Discontinued None 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
01/19/2012 ORIG-1 Approval

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/20/2025 SUPPL-9 Labeling-Package Insert

Label is not available on this site.
04/25/2023 SUPPL-7 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.
04/25/2023 SUPPL-5 Labeling-Package Insert

Label is not available on this site.
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