Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062597
Company: SAVAGE LABS
Company: SAVAGE LABS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MYTREX F | NYSTATIN; TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% | 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 |
---|---|---|---|---|---|---|---|
10/08/1985 | 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 |
---|---|---|---|---|---|
03/07/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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07/25/1995 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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04/25/1994 | SUPPL-1 | Labeling |
Label is not available on this site. |