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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 062606

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100,000 UNITS/GM;0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons*
Marketing Status: Discontinued
Active Ingredient: NYSTATIN; TRIAMCINOLONE ACETONIDE
Proprietary Name: MYCOLOG-II
Dosage Form; Route of Administration: CREAM; TOPICAL
Strength: 100,000 UNITS/GM;0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons*
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A062606
Product Number: 001
Approval Date: May 15, 1985
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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