Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074027
Company: COSETTE
Company: COSETTE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DESONIDE | 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 |
---|---|---|---|---|---|---|---|
09/28/1992 | 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 |
---|---|---|---|---|---|
06/16/2015 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
03/23/1999 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/31/1996 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
DESONIDE
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 |