Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 060572
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TRIAMCINOLONE ACETONIDE 100,000 UNITS/GM;0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** OINTMENT;TOPICAL Discontinued None No No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.

11/03/1992 SUPPL-17 Labeling

Label is not available on this site.

03/23/1992 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

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