Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 202895

PREZISTA (DARUNAVIR ETHANOLATE)
EQ 100MG BASE/ML Marketing Status: Prescription

Active Ingredient: DARUNAVIR ETHANOLATE
Proprietary Name: PREZISTA
Dosage Form; Route of Administration: SUSPENSION; ORAL
Strength: EQ 100MG BASE/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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