Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088607
Company: COSETTE
Company: COSETTE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GYNE-SULF | 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 |
|---|---|---|---|---|---|---|---|
| 06/09/1986 | 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 |
|---|---|---|---|---|---|
| 11/08/1996 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/23/1990 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 09/20/1991 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 12/19/1988 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/19/1988 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/13/1987 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/13/1987 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/13/1987 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/13/1987 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |