Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 085539
Company: IVAX PHARMS
Company: IVAX PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FLUTEX | TRIAMCINOLONE ACETONIDE | 0.025% | CREAM;TOPICAL | Discontinued | None | No | No |
| FLUTEX | TRIAMCINOLONE ACETONIDE | 0.1% | CREAM;TOPICAL | Discontinued | None | No | No |
| FLUTEX | TRIAMCINOLONE ACETONIDE | 0.5% | CREAM;TOPICAL | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 06/23/1978 | 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 |
|---|---|---|---|---|---|
| 12/11/1990 | SUPPL-8 | Labeling |
Label is not available on this site. |