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Last Updated: April 22, 2024

Details for New Drug Application (NDA): 208464

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NDA 208464 describes VEMLIDY, which is a drug marketed by Gilead Sciences Inc and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the VEMLIDY profile page.

The generic ingredient in VEMLIDY is tenofovir alafenamide fumarate. There are forty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the tenofovir alafenamide fumarate profile page.
Summary for 208464
Applicant:Gilead Sciences Inc
Ingredient:tenofovir alafenamide fumarate
Pharmacology for NDA: 208464
Suppliers and Packaging for NDA: 208464
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VEMLIDY tenofovir alafenamide fumarate TABLET;ORAL 208464 NDA Gilead Sciences, Inc. 61958-2301 61958-2301-1 30 TABLET in 1 BOTTLE, PLASTIC (61958-2301-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 25MG BASE
Approval Date:Nov 10, 2016TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Oct 17, 2025
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:⤷  Try a TrialPatent Expiration:Oct 17, 2025Product Flag?Substance Flag?Delist Request?Y
Patent:⤷  Try a TrialPatent Expiration:Feb 15, 2033Product Flag?Substance Flag?Delist Request?Y

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