Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062367
Company: COSETTE
Company: COSETTE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MYKACET | NYSTATIN; TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | CREAM;TOPICAL | 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 |
|---|---|---|---|---|---|---|---|
| 05/28/1985 | 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 |
|---|---|---|---|---|---|
| 05/30/2001 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/29/2000 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/16/1998 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/18/1997 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/18/1997 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/18/1997 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/18/1997 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/18/1997 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/28/1996 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/07/1996 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/10/1995 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/10/1995 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/28/1994 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/11/1993 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/22/1993 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/22/1993 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 12/22/1993 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |