Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019048
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% | 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. |
||
| 05/11/1995 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 01/18/1994 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/03/1993 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/30/1993 | SUPPL-9 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 08/30/1991 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 08/18/1989 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/28/1989 | SUPPL-5 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 11/23/1988 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 10/25/1985 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/26/1985 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 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 PHARMS NC |
| DESONIDE | DESONIDE | 0.05% | CREAM;TOPICAL | Prescription | No | AB | 073548 | SUN PHARMA CANADA |
| DESOWEN | DESONIDE | 0.05% | CREAM;TOPICAL | Prescription | No | AB | 019048 | GALDERMA LABS LP |