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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 021752


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NDA 021752 describes TRUVADA, which is a drug marketed by Gilead and is included in one NDA. It is available from one supplier. There are four patents protecting this drug and two Paragraph IV challenges. Additional details are available on the TRUVADA profile page.

The generic ingredient in TRUVADA is emtricitabine; tenofovir disoproxil fumarate. There are eighteen drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the emtricitabine; tenofovir disoproxil fumarate profile page.
Summary for 021752
Tradename:TRUVADA
Applicant:Gilead
Ingredient:emtricitabine; tenofovir disoproxil fumarate
Patents:4
Pharmacology for NDA: 021752
Suppliers and Packaging for NDA: 021752
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752 NDA Gilead Sciences, Inc 61958-0701 61958-0701-1 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-0701-1)
TRUVADA emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021752 NDA Gilead Sciences, Inc 61958-0703 61958-0703-1 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-0703-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG;300MG
Approval Date:Aug 2, 2004TE:ABRLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Jan 13, 2024Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATMENT OF ADULTS INFECTED WITH HIV-1
Patent:⤷  Try a TrialPatent Expiration:Jan 13, 2024Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF HIV
Patent:⤷  Try a TrialPatent Expiration:Jan 13, 2024Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER

Expired US Patents for NDA 021752

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