Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084579
Company: BARR
Company: BARR
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
RESERPINE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; RESERPINE | 50MG;0.125MG | 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 |
---|---|---|---|---|---|---|---|
09/30/1975 | 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 |
---|---|---|---|---|---|
02/14/1992 | SUPPL-37 | Labeling |
Label is not available on this site. |
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01/22/1991 | SUPPL-36 | Labeling |
Label is not available on this site. |
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08/23/1989 | SUPPL-35 | Labeling |
Label is not available on this site. |
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03/24/1989 | SUPPL-34 | Labeling |
Label is not available on this site. |
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06/16/1989 | SUPPL-33 | Labeling |
Label is not available on this site. |