Drugs@FDA: FDA-Approved Drugs
Company: GALDERMA LABS LP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DESOWEN | DESONIDE | 0.05% | CREAM;TOPICAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
12/14/1984 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/13/2013 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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05/11/1995 | SUPPL-12 | Labeling |
Label is not available on this site. |
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01/18/1994 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/03/1993 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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09/30/1993 | SUPPL-9 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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08/30/1991 | SUPPL-7 | Labeling |
Label is not available on this site. |
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08/18/1989 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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08/28/1989 | SUPPL-5 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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11/23/1988 | SUPPL-4 | Labeling |
Label is not available on this site. |
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10/25/1985 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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06/26/1985 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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06/14/1985 | SUPPL-1 | Labeling |
Label is not available on this site. |
DESOWEN
CREAM;TOPICAL; 0.05%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DESONIDE | DESONIDE | 0.05% | CREAM;TOPICAL | Prescription | No | AB | 214396 | ALEMBIC |
DESONIDE | DESONIDE | 0.05% | CREAM;TOPICAL | Prescription | No | AB | 210198 | CADILA |
DESONIDE | DESONIDE | 0.05% | CREAM;TOPICAL | Prescription | No | AB | 074027 | COSETTE |
DESONIDE | DESONIDE | 0.05% | CREAM;TOPICAL | Prescription | No | AB | 209729 | GLENMARK SPECLT |
DESONIDE | DESONIDE | 0.05% | CREAM;TOPICAL | Prescription | Yes | AB | 017010 | PADAGIS US |
DESONIDE | DESONIDE | 0.05% | CREAM;TOPICAL | Prescription | No | AB | 073548 | TARO |
DESOWEN | DESONIDE | 0.05% | CREAM;TOPICAL | Prescription | No | AB | 019048 | GALDERMA LABS LP |