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Details for New Drug Application (NDA): 203093

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NDA 203093 describes VITEKTA, 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 VITEKTA profile page.

The generic ingredient in VITEKTA is elvitegravir. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the elvitegravir profile page.

Summary for NDA: 203093

Tradename:
VITEKTA
Applicant:
Gilead Sciences Inc
Ingredient:
elvitegravir
Patents:3
Formulation / Manufacturing:see details

Pharmacology for NDA: 203093

Suppliers and Packaging for NDA: 203093

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VITEKTA
elvitegravir
TABLET;ORAL 203093 NDA Gilead Sciences, Inc. 61958-1301 61958-1301-1 30 TABLET, FILM COATED in 1 BOTTLE (61958-1301-1)
VITEKTA
elvitegravir
TABLET;ORAL 203093 NDA Gilead Sciences, Inc. 61958-1302 61958-1302-1 30 TABLET, FILM COATED in 1 BOTTLE (61958-1302-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength85MG
Approval Date:Sep 24, 2014TE:RLD:No
Patent:8,981,103Patent Expiration:Oct 26, 2026Product Flag?YSubstance Flag?YDelist Request?
Regulatory Exclusivity Expiration:Sep 24, 2017
Regulatory Exclusivity Use:NEW PRODUCT
Patent:7,176,220Patent Expiration:Nov 20, 2023Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF HIV INFECTION


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