Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084580
Company: BARR
Company: BARR
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RESERPINE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; RESERPINE | 25MG;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 |
|---|---|---|---|---|---|---|---|
| 05/30/1975 | 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-35 | Labeling |
Label is not available on this site. |
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| 01/22/1991 | SUPPL-34 | Labeling |
Label is not available on this site. |
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| 03/06/1989 | SUPPL-31 | Labeling |
Label is not available on this site. |
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| 06/16/1989 | SUPPL-30 | Labeling |
Label is not available on this site. |