Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 212477

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HARVONI (LEDIPASVIR; SOFOSBUVIR)
33.75MG;150MG/PACKET
Marketing Status: Prescription

Active Ingredient: LEDIPASVIR; SOFOSBUVIR
Proprietary Name: HARVONI
Dosage Form; Route of Administration: PELLETS; ORAL
Strength: 33.75MG;150MG/PACKET
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N212477
Product Number: 001
Approval Date: Aug 28, 2019
Applicant Holder Full Name: GILEAD SCIENCES INC
Marketing Status:  Prescription
Patent and Exclusivity Information

HARVONI (LEDIPASVIR; SOFOSBUVIR)
45MG;200MG/PACKET
Marketing Status: Prescription

Active Ingredient: LEDIPASVIR; SOFOSBUVIR
Proprietary Name: HARVONI
Dosage Form; Route of Administration: PELLETS; ORAL
Strength: 45MG;200MG/PACKET
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N212477
Product Number: 002
Approval Date: Aug 28, 2019
Applicant Holder Full Name: GILEAD SCIENCES INC
Marketing Status:  Prescription
Patent and Exclusivity Information