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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 062506

NYSTATIN (NYSTATIN)
500,000 UNITS
Marketing Status: Prescription
Active Ingredient: NYSTATIN
Proprietary Name: NYSTATIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 500,000 UNITS
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AA
Application Number: A062506
Product Number: 001
Approval Date: Jan 16, 1984
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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