Drugs@FDA: FDA-Approved Drugs
Company: TEVA
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 |
---|---|---|---|---|---|---|---|
02/06/1989 | 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 |
---|---|---|---|---|---|
08/30/2001 | SUPPL-21 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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07/07/2000 | SUPPL-20 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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02/17/2000 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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04/09/1997 | SUPPL-18 | Labeling |
Label is not available on this site. |
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06/13/1996 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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08/07/1995 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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05/04/1995 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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05/04/1995 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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05/04/1995 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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05/04/1995 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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02/13/1995 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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02/13/1995 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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02/13/1995 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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02/13/1995 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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02/13/1995 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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08/31/1993 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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08/31/1993 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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04/01/1993 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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09/30/1991 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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10/13/1992 | 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 |