Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 065203

100,000 UNITS/GM
Marketing Status: Prescription
Active Ingredient: NYSTATIN
Proprietary Name: NYSTATIN
Dosage Form; Route of Administration: POWDER; TOPICAL
Strength: 100,000 UNITS/GM
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AT
Application Number: A065203
Product Number: 001
Approval Date: Jul 15, 2004
Applicant Holder Full Name: MAYNE PHARMA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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