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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 216593

Marketing Status: Prescription
Active Ingredient: HYDROXYUREA
Proprietary Name: XROMI
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 100MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N216593
Product Number: 001
Approval Date: Apr 4, 2024
Applicant Holder Full Name: NOVA LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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