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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 219016

EDURANT PED (RILPIVIRINE HYDROCHLORIDE)
EQ 2.5MG BASE
Marketing Status: Prescription
Active Ingredient: RILPIVIRINE HYDROCHLORIDE
Proprietary Name: EDURANT PED
Dosage Form; Route of Administration: TABLET, FOR SUSPENSION; ORAL
Strength: EQ 2.5MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N219016
Product Number: 001
Approval Date: Mar 15, 2024
Applicant Holder Full Name: JANSSEN PRODUCTS LP
Marketing Status:  Prescription
Patent and Exclusivity Information
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