Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 214187

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EPCLUSA (SOFOSBUVIR; VELPATASVIR)
150MG;37.5MG/PACKET
Marketing Status: Prescription

Active Ingredient: SOFOSBUVIR; VELPATASVIR
Proprietary Name: EPCLUSA
Dosage Form; Route of Administration: PELLETS; ORAL
Strength: 150MG;37.5MG/PACKET
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N214187
Product Number: 001
Approval Date: Jun 10, 2021
Applicant Holder Full Name: GILEAD SCIENCES INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: SOFOSBUVIR; VELPATASVIR
Proprietary Name: EPCLUSA
Dosage Form; Route of Administration: PELLETS; ORAL
Strength: 200MG;50MG/PACKET
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N214187
Product Number: 002
Approval Date: Jun 10, 2021
Applicant Holder Full Name: GILEAD SCIENCES INC
Marketing Status:  Prescription
Patent and Exclusivity Information