Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090654
Company: SUN PHARM INDS
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 |
---|---|---|---|---|---|
04/25/2023 | SUPPL-7 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
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04/25/2023 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |