Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 073085
Company: COSETTE
Company: COSETTE
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 |
---|---|---|---|---|---|---|---|
02/14/1992 | 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 |
---|---|---|---|---|---|
07/05/2001 | SUPPL-8 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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12/29/2000 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/07/1997 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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04/07/1997 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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04/07/1997 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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04/07/1997 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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06/28/1996 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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12/22/1993 | SUPPL-1 | Labeling |
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 |