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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 215727

Marketing Status: Prescription
Active Ingredient: COLCHICINE
Proprietary Name: LODOCO
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.5MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215727
Product Number: 001
Approval Date: Jun 16, 2023
Applicant Holder Full Name: AGEPHA PHARMA FZ LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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