Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 060572
Company: MYLAN
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MYCOLOG-II | NYSTATIN; TRIAMCINOLONE ACETONIDE | 100,000 UNITS/GM;0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT;TOPICAL | Discontinued | None | No | No |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 |
|---|---|---|---|---|---|---|---|
| 06/28/1985 | 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 |
|---|---|---|---|---|---|
| 11/30/1995 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/03/1992 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 03/23/1992 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |