Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074935
Company: TARO
Company: TARO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLUOCINONIDE | FLUOCINONIDE | 0.05% | GEL;TOPICAL | Prescription | AB | No | 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 |
---|---|---|---|---|---|---|---|
07/29/1997 | 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 |
---|---|---|---|---|---|
04/16/2004 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
07/27/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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01/28/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/28/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
FLUOCINONIDE
GEL;TOPICAL; 0.05%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FLUOCINONIDE | FLUOCINONIDE | 0.05% | GEL;TOPICAL | Prescription | No | AB | 072933 | FOUGERA PHARMS INC |
FLUOCINONIDE | FLUOCINONIDE | 0.05% | GEL;TOPICAL | Prescription | No | AB | 074935 | TARO |