Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208341

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EPCLUSA (SOFOSBUVIR; VELPATASVIR)
200MG;50MG
Marketing Status: Prescription

Active Ingredient: SOFOSBUVIR; VELPATASVIR
Proprietary Name: EPCLUSA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 200MG;50MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208341
Product Number: 002
Approval Date: Mar 19, 2020
Applicant Holder Full Name: GILEAD SCIENCES INC
Marketing Status:  Prescription
Patent and Exclusivity Information

EPCLUSA (SOFOSBUVIR; VELPATASVIR)
400MG;100MG
Marketing Status: Prescription

Active Ingredient: SOFOSBUVIR; VELPATASVIR
Proprietary Name: EPCLUSA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 400MG;100MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208341
Product Number: 001
Approval Date: Jun 28, 2016
Applicant Holder Full Name: GILEAD SCIENCES INC
Marketing Status:  Prescription
Patent and Exclusivity Information