Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208351

ODEFSEY (EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE)
200MG;EQ 25MG BASE;EQ 25MG BASE Marketing Status: Prescription

Active Ingredient: EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE
Proprietary Name: ODEFSEY
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG;EQ 25MG BASE;EQ 25MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208351
Product Number: 001
Approval Date: Mar 1, 2016
Applicant Holder Full Name: GILEAD SCIENCES INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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