Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071500
Company: TARO
Company: TARO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FLUOCINONIDE | FLUOCINONIDE | 0.05% | CREAM;TOPICAL | Prescription | AB1 | 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 |
|---|---|---|---|---|---|---|---|
| 06/10/1987 | 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 |
|---|---|---|---|---|---|
| 08/14/2001 | SUPPL-20 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 09/30/1993 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 02/26/1993 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 01/25/1993 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 12/31/1990 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 09/21/1989 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 09/13/1990 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/27/1989 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/26/1989 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/02/1989 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/03/1988 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 07/08/1988 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 07/08/1988 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/08/1988 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/10/1987 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/10/1987 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/24/1987 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
FLUOCINONIDE
CREAM;TOPICAL; 0.05%
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| FLUOCINONIDE | FLUOCINONIDE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 210554 | AMNEAL |
| FLUOCINONIDE | FLUOCINONIDE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 073085 | COSETTE |
| FLUOCINONIDE | FLUOCINONIDE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 073030 | FOUGERA PHARMS INC |
| FLUOCINONIDE | FLUOCINONIDE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 071500 | TARO |
| FLUOCINONIDE | FLUOCINONIDE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 072488 | TEVA |