Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071425
Company: GALDERMA LABS LP
Company: GALDERMA LABS LP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DESOWEN | DESONIDE | 0.05% | OINTMENT;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 |
---|---|---|---|---|---|---|---|
06/15/1988 | 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 |
---|---|---|---|---|---|
01/31/1997 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
11/01/1994 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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05/19/1993 | SUPPL-4 | Labeling |
Label is not available on this site. |
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10/30/1992 | SUPPL-3 | Labeling |
Label is not available on this site. |
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11/06/1991 | SUPPL-2 | Labeling |
Label is not available on this site. |
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08/29/1989 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
DESOWEN
OINTMENT;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% | OINTMENT;TOPICAL | Prescription | No | AB | 212473 | ALEMBIC |
DESONIDE | DESONIDE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 210998 | ENCUBE ETHICALS |
DESONIDE | DESONIDE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 075751 | FOUGERA PHARMS |
DESONIDE | DESONIDE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 209996 | GLENMARK PHARMS LTD |
DESONIDE | DESONIDE | 0.05% | OINTMENT;TOPICAL | Prescription | Yes | AB | 017426 | PADAGIS US |
DESONIDE | DESONIDE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 074254 | TARO |
DESOWEN | DESONIDE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 071425 | GALDERMA LABS LP |