Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087102
Company: TARO
Company: TARO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | 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 |
|---|---|---|---|---|---|---|---|
| 04/27/1982 | 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 |
|---|---|---|---|---|---|
| 07/31/1996 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 03/29/1993 | SUPPL-28 | Labeling |
Label is not available on this site. |
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| 03/29/1993 | SUPPL-27 | Labeling |
Label is not available on this site. |
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| 11/16/1992 | SUPPL-26 | Labeling |
Label is not available on this site. |
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| 03/15/1991 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 01/07/1991 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 09/19/1989 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 01/03/1990 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/13/1992 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/25/1988 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 10/07/1986 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/10/1986 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/12/1984 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/29/1984 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/15/1983 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/03/1983 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |