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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 062129

NYSTATIN (NYSTATIN)
100,000 UNITS/GM
Marketing Status: Prescription
Active Ingredient: NYSTATIN
Proprietary Name: NYSTATIN
Dosage Form; Route of Administration: CREAM; TOPICAL
Strength: 100,000 UNITS/GM
Reference Listed Drug: No
Reference Standard: No
TE Code: AT
Application Number: A062129
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: FOUGERA PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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