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Details for New Drug Application (NDA): 021896

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NDA 021896 describes EMTRIVA, which is a drug marketed by Gilead and is included in two NDAs. It is available from five suppliers. There are four patents protecting this drug. Additional details are available on the EMTRIVA profile page.

The generic ingredient in EMTRIVA is emtricitabine. There are fifteen drug master file entries for this compound. Five suppliers are listed for this compound. There are ten tentative approvals for this compound. Additional details are available on the emtricitabine profile page.

Summary for NDA: 021896

Tradename:
EMTRIVA
Applicant:
Gilead
Ingredient:
emtricitabine
Patents:4
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 021896

Suppliers and Packaging for NDA: 021896

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EMTRIVA
emtricitabine
SOLUTION;ORAL 021896 NDA Gilead Sciences, Inc. 61958-0602 61958-0602-1 1 BOTTLE, DISPENSING in 1 CARTON (61958-0602-1) > 170 mL in 1 BOTTLE, DISPENSING

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength10MG/ML
Approval Date:Sep 28, 2005TE: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:6,642,245*PEDPatent Expiration:May 4, 2021Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021896

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead
EMTRIVA
emtricitabine
SOLUTION;ORAL021896-001Sep 28, 20055,210,085*PED► subscribe
Gilead
EMTRIVA
emtricitabine
SOLUTION;ORAL021896-001Sep 28, 20055,814,639*PED► subscribe
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