Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 210251

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BIKTARVY (BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE)
EQ 30MG BASE;120MG;EQ 15MG BASE
Marketing Status: Prescription

Active Ingredient: BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Proprietary Name: BIKTARVY
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 30MG BASE;120MG;EQ 15MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N210251
Product Number: 002
Approval Date: Oct 7, 2021
Applicant Holder Full Name: GILEAD SCIENCES INC
Marketing Status:  Prescription
Patent and Exclusivity Information

BIKTARVY (BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE)
EQ 50MG BASE;200MG;EQ 25MG BASE
Marketing Status: Prescription

Active Ingredient: BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Proprietary Name: BIKTARVY
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 50MG BASE;200MG;EQ 25MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N210251
Product Number: 001
Approval Date: Feb 7, 2018
Applicant Holder Full Name: GILEAD SCIENCES INC
Marketing Status:  Prescription
Patent and Exclusivity Information