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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 020498

CASODEX (BICALUTAMIDE)
50MG
Marketing Status: Prescription
Active Ingredient: BICALUTAMIDE
Proprietary Name: CASODEX
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020498
Product Number: 001
Approval Date: Oct 4, 1995
Applicant Holder Full Name: ANI PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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