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Generated: June 16, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021356

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NDA 021356 describes VIREAD, which is a drug marketed by Gilead Sciences Inc and is included in two NDAs. It is available from five suppliers. 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. Seventeen suppliers are listed for this compound. Additional details are available on the tenofovir disoproxil fumarate profile page.
Summary for 021356
Tradename:VIREAD
Applicant:Gilead Sciences Inc
Ingredient:tenofovir disoproxil fumarate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021356
Suppliers and Packaging for NDA: 021356
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VIREAD tenofovir disoproxil fumarate TABLET;ORAL 021356 NDA A-S Medication Solutions 50090-0754 50090-0754-0 30 TABLET, COATED in 1 BOTTLE, PLASTIC (50090-0754-0)
VIREAD tenofovir disoproxil fumarate TABLET;ORAL 021356 NDA State of Florida DOH Central Pharmacy 53808-0810 53808-0810-1 30 TABLET, COATED in 1 BLISTER PACK (53808-0810-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Oct 26, 2001TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Dec 11, 2021
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Jun 11, 2022
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Jan 18, 2012TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Dec 11, 2021
Regulatory Exclusivity Use:NEW PATIENT POPULATION

Expired US Patents for NDA 021356

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