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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 202895

PREZISTA (DARUNAVIR)
100MG/ML
Marketing Status: Prescription
Active Ingredient: DARUNAVIR
Proprietary Name: PREZISTA
Dosage Form; Route of Administration: SUSPENSION; ORAL
Strength: 100MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N202895
Product Number: 001
Approval Date: Dec 16, 2011
Applicant Holder Full Name: JANSSEN PRODUCTS LP
Marketing Status:  Prescription
Patent and Exclusivity Information
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