Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 072494
Company: TARO
Company: TARO
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FLUOCINONIDE EMULSIFIED BASE | FLUOCINONIDE | 0.05% | CREAM;TOPICAL | Prescription | AB2 | 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 |
---|---|---|---|---|---|---|---|
01/19/1989 | 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 |
---|---|---|---|---|---|
04/13/2004 | SUPPL-7 | Labeling |
Label is not available on this site. |
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09/13/1996 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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09/17/1996 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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10/06/1995 | SUPPL-3 | Labeling |
Label is not available on this site. |
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05/15/1996 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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02/11/1991 | SUPPL-1 | Labeling |
Label is not available on this site. |
FLUOCINONIDE EMULSIFIED BASE
CREAM;TOPICAL; 0.05%
TE Code = AB2
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FLUOCINONIDE EMULSIFIED BASE | FLUOCINONIDE | 0.05% | CREAM;TOPICAL | Prescription | No | AB2 | 074204 | COSETTE |
FLUOCINONIDE EMULSIFIED BASE | FLUOCINONIDE | 0.05% | CREAM;TOPICAL | Prescription | No | AB2 | 076586 | FOUGERA PHARMS |
FLUOCINONIDE EMULSIFIED BASE | FLUOCINONIDE | 0.05% | CREAM;TOPICAL | Prescription | No | AB2 | 072494 | TARO |
FLUOCINONIDE EMULSIFIED BASE | FLUOCINONIDE | 0.05% | CREAM;TOPICAL | Prescription | No | AB2 | 072490 | TEVA |