Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 210455

SYMTUZA (COBICISTAT; DARUNAVIR ETHANOLATE; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE)
150MG;EQ 800MG BASE;200MG;EQ 10MG BASE Marketing Status: Prescription

Active Ingredient: COBICISTAT; DARUNAVIR ETHANOLATE; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE
Proprietary Name: SYMTUZA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 150MG;EQ 800MG BASE;200MG;EQ 10MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N210455
Product Number: 001
Approval Date: Jul 17, 2018
Applicant Holder Full Name: JANSSEN PRODUCTS LP
Marketing Status:  Prescription
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