Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 205834

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

Active Ingredient: LEDIPASVIR; SOFOSBUVIR
Proprietary Name: HARVONI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 45MG;200MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N205834
Product Number: 002
Approval Date: Aug 28, 2019
Applicant Holder Full Name: GILEAD SCIENCES INC
Marketing Status:  Prescription
Patent and Exclusivity Information

HARVONI (LEDIPASVIR; SOFOSBUVIR)
90MG;400MG
Marketing Status: Prescription

Active Ingredient: LEDIPASVIR; SOFOSBUVIR
Proprietary Name: HARVONI
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 90MG;400MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N205834
Product Number: 001
Approval Date: Oct 10, 2014
Applicant Holder Full Name: GILEAD SCIENCES INC
Marketing Status:  Prescription
Patent and Exclusivity Information