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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 212687

Marketing Status: Prescription
Active Ingredient: PIRFENIDONE
Proprietary Name: PIRFENIDONE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 267MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A212687
Product Number: 001
Approval Date: Jun 9, 2023
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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