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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 075340

HYDROXYUREA (HYDROXYUREA)
500MG
Marketing Status: Prescription
Active Ingredient: HYDROXYUREA
Proprietary Name: HYDROXYUREA
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 500MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A075340
Product Number: 001
Approval Date: Feb 24, 1999
Applicant Holder Full Name: ENDO OPERATIONS LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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