Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 073548
Company: TARO
Company: TARO
| 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 |
|---|---|---|---|---|---|---|---|
| 06/30/1992 | 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 |
|---|---|---|---|---|---|
| 01/15/2016 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/18/1999 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/18/1999 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/20/1998 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/17/1997 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/17/1997 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/17/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/01/1996 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/01/1996 | 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 PHARMS |
| 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 |