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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 016885

LYSODREN (MITOTANE)
500MG
Marketing Status: Prescription
Active Ingredient: MITOTANE
Proprietary Name: LYSODREN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 500MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N016885
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: HRA PHARMA RARE DISEASES
Marketing Status:  Prescription
Patent and Exclusivity Information
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