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Details for New Drug Application (NDA): 021500

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NDA 021500 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: 021500

Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Pharmacology for NDA: 021500

Suppliers and Packaging for NDA: 021500

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPSULE;ORAL 021500 NDA REMEDYREPACK INC. 24236-297 24236-297-02 30 CAPSULE in 1 BLISTER PACK (24236-297-02)
CAPSULE;ORAL 021500 NDA Excella GmbH 46014-0601 46014-0601-1 30 CAPSULE in 1 BOTTLE, PLASTIC (46014-0601-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Jul 2, 2003TE: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: 021500

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
CAPSULE;ORAL021500-001Jul 2, 20035,210,085*PED► subscribe
CAPSULE;ORAL021500-001Jul 2, 20035,814,639*PED► subscribe
CAPSULE;ORAL021500-001Jul 2, 20037,402,588*PED► subscribe
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