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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208215

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DESCOVY (EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE)
120MG;EQ 15MG BASE
Marketing Status: Prescription
Active Ingredient: EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Proprietary Name: DESCOVY
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 120MG;EQ 15MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208215
Product Number: 002
Approval Date: Jan 7, 2022
Applicant Holder Full Name: GILEAD SCIENCES INC
Marketing Status:  Prescription
Patent and Exclusivity Information
DESCOVY (EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE)
200MG;EQ 25MG BASE
Marketing Status: Prescription
Active Ingredient: EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Proprietary Name: DESCOVY
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG;EQ 25MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208215
Product Number: 001
Approval Date: Apr 4, 2016
Applicant Holder Full Name: GILEAD SCIENCES INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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