Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071535
Company: COSETTE
Company: COSETTE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FLUOCINONIDE | FLUOCINONIDE | 0.05% | SOLUTION;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 |
|---|---|---|---|---|---|---|---|
| 12/02/1988 | 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 |
|---|---|---|---|---|---|
| 02/06/2015 | SUPPL-17 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 07/21/1992 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/21/1992 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/18/1992 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/21/1992 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/21/1992 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/04/1992 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 07/18/1989 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |