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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 215973

SUNLENCA (LENACAPAVIR SODIUM)
EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)
Marketing Status: Prescription
Active Ingredient: LENACAPAVIR SODIUM
Proprietary Name: SUNLENCA
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215973
Product Number: 001
Approval Date: Dec 22, 2022
Applicant Holder Full Name: GILEAD SCIENCES INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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