Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088850
Company: PAR PHARM
Company: PAR PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDROFLUMETHIAZIDE | HYDROFLUMETHIAZIDE | 50MG | 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 |
|---|---|---|---|---|---|---|---|
| 05/31/1985 | 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-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/22/1991 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 03/11/1991 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 11/14/1988 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 09/08/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |