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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 204820

MITIGARE (COLCHICINE)
0.6MG
Marketing Status: Prescription
Active Ingredient: COLCHICINE
Proprietary Name: MITIGARE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 0.6MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N204820
Product Number: 001
Approval Date: Sep 26, 2014
Applicant Holder Full Name: HIKMA INTERNATIONAL PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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