Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087104
Company: TARO
Company: TARO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.025% | CREAM;TOPICAL | Prescription | AT | 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-30 | 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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| 11/16/1992 | SUPPL-27 | Labeling |
Label is not available on this site. |
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| 02/11/1991 | SUPPL-25 | Labeling |
Label is not available on this site. |
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| 02/11/1991 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 01/19/1990 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 01/03/1990 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/16/1989 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 10/07/1986 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/13/1985 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/12/1984 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/09/1983 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/30/1982 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
FLUOCINOLONE ACETONIDE
CREAM;TOPICAL; 0.025%
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.025% | CREAM;TOPICAL | Prescription | No | AT | 210747 | COSETTE |
| FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.025% | CREAM;TOPICAL | Prescription | No | AT | 088169 | FOUGERA PHARMS INC |
| FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.025% | CREAM;TOPICAL | Prescription | No | AT | 087104 | TARO |
| SYNALAR | FLUOCINOLONE ACETONIDE | 0.025% | CREAM;TOPICAL | Prescription | Yes | AT | 012787 | MEDIMETRIKS PHARMS |