Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087285
Company: PADAGIS US
Company: PADAGIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRIPLE SULFA | TRIPLE SULFA (SULFABENZAMIDE;SULFACETAMIDE;SULFATHIAZOLE) | 3.7%;2.86%;3.42% | CREAM;VAGINAL | 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 |
|---|---|---|---|---|---|---|---|
| 11/15/1982 | 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 |
|---|---|---|---|---|---|
| 09/16/1997 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/29/1996 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/07/1995 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/18/1995 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/04/1992 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 08/07/1995 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/28/1987 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |