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Last Updated: May 25, 2022

Details for New Drug Application (NDA): 022577

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NDA 022577 describes VIREAD, which is a drug marketed by Gilead Sciences Inc and is included in two NDAs. It is available from one supplier. Additional details are available on the VIREAD profile page.

The generic ingredient in VIREAD is tenofovir disoproxil fumarate. There are forty-two drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the tenofovir disoproxil fumarate profile page.
Summary for 022577
Applicant:Gilead Sciences Inc
Ingredient:tenofovir disoproxil fumarate
Formulation / Manufacturing:see details
Pharmacology for NDA: 022577
Suppliers and Packaging for NDA: 022577
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VIREAD tenofovir disoproxil fumarate POWDER;ORAL 022577 NDA Gilead Sciences, Inc. 61958-0403 61958-0403-1 1 BOTTLE, PLASTIC in 1 CARTON (61958-0403-1) > 60 g in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;ORALStrength40MG/SCOOPFUL
Approval Date:Jan 18, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 11, 2022
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY

Expired US Patents for NDA 022577

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Johnson and Johnson

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