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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 208452

EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE (EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE)
200MG;EQ 25MG BASE;300MG
Marketing Status: Prescription
Active Ingredient: EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE
Proprietary Name: EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG;EQ 25MG BASE;300MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A208452
Product Number: 001
Approval Date: May 20, 2025
Applicant Holder Full Name: MYLAN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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