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Generated: November 19, 2018

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Details for New Drug Application (NDA): 021937

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NDA 021937 describes ATRIPLA, which is a drug marketed by Gilead Sciences and is included in one NDA. It is available from four suppliers. There are sixteen patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ATRIPLA profile page.

The generic ingredient in ATRIPLA is efavirenz; emtricitabine; tenofovir disoproxil fumarate. There are twenty-six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the efavirenz; emtricitabine; tenofovir disoproxil fumarate profile page.
Summary for 021937
Suppliers and Packaging for NDA: 021937
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937 NDA Gilead Sciences, LLC 15584-0101 15584-0101-1 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (15584-0101-1)
ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937 NDA A-S Medication Solutions 50090-0980 50090-0980-0 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-0980-0)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG;200MG;300MG
Approval Date:Jul 12, 2006TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Jan 2, 2018Product Flag?Substance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Jan 25, 2018Product Flag?Substance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Jan 25, 2018Product Flag?Substance Flag?Delist Request?

Expired US Patents for NDA 021937

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QuintilesIMS
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Accenture
Boehringer Ingelheim

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