Drugs@FDA: FDA-Approved Drugs
Company: TARO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FLUOCINONIDE | FLUOCINONIDE | 0.05% | CREAM;TOPICAL | Prescription | AB1 | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 06/26/1984 | 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 |
|---|---|---|---|---|---|
| 11/10/2015 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/27/2014 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/05/2015 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/01/2003 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 05/09/2001 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/17/1996 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/14/1996 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/09/1993 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/19/1991 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 11/04/1991 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/30/1991 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/30/1991 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/12/1989 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 03/08/1985 | SUPPL-2 | 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 PHARMS LLC |
| 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 | Yes | AB1 | 019117 | TARO |
| FLUOCINONIDE | FLUOCINONIDE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 071500 | TARO |
| FLUOCINONIDE | FLUOCINONIDE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 211410 | TELIGENT PHARMA INC |
| FLUOCINONIDE | FLUOCINONIDE | 0.05% | CREAM;TOPICAL | Prescription | No | AB1 | 072488 | TEVA |
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