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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 nine suppliers. There are twelve patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TRUVADA profile page.

The generic ingredient in TRUVADA is emtricitabine; tenofovir disoproxil fumarate. There are fifteen drug master file entries for this compound. Nine suppliers are listed for this compound. There are six tentative approvals for this compound. Additional details are available on the emtricitabine; tenofovir disoproxil fumarate profile page.

Summary for NDA: 021752

emtricitabine; tenofovir disoproxil fumarate
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 021752

Suppliers and Packaging for NDA: 021752

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL 021752 NDA Lake Erie Medical DBA Quality Care Products LLC 35356-070 35356-070-03 3 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (35356-070-03)
emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL 021752 NDA A-S Medication Solutions 50090-0870 50090-0870-0 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-0870-0)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG;300MG
Approval Date:Aug 2, 2004TE:RLD:Yes
Patent:5,814,639*PEDPatent Expiration:Mar 29, 2016Product Flag?Substance Flag?Delist Request?Y
Patent:5,914,331*PEDPatent Expiration:Jan 2, 2018Product Flag?Substance Flag?Delist Request?Y
Patent:5,922,695*PEDPatent Expiration:Jan 25, 2018Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021752

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021752-004Mar 10, 20165,814,639*PED► subscribe
emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021752-001Aug 2, 20045,814,639*PED► subscribe
emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021752-002Mar 10, 20165,814,639*PED► subscribe
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