Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088907
Company: PAR PHARM
Company: PAR PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RESERPINE AND HYDROFLUMETHIAZIDE | HYDROFLUMETHIAZIDE; 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 |
|---|---|---|---|---|---|---|---|
| 09/20/1985 | 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 |
|---|---|---|---|---|---|
| 06/07/1996 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/21/1989 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 10/07/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |