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Last Updated: April 3, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091471


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NDA 091471 describes EFAVIRENZ, which is a drug marketed by Aurobindo Pharma Ltd, Cipla, Hetero Labs Ltd Iii, Mylan, Strides Pharma, Teva Pharms Usa, and Macleods Pharms Ltd, and is included in twelve NDAs. It is available from seven suppliers. Additional details are available on the EFAVIRENZ profile page.

The generic ingredient in EFAVIRENZ is efavirenz; lamivudine; tenofovir disoproxil fumarate. There are twenty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the efavirenz; lamivudine; tenofovir disoproxil fumarate profile page.
Summary for 091471
Tradename:EFAVIRENZ
Applicant:Mylan
Ingredient:efavirenz
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 091471
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EFAVIRENZ efavirenz TABLET;ORAL 091471 ANDA Mylan Pharmaceuticals Inc. 0378-2233 0378-2233-93 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2233-93)
EFAVIRENZ efavirenz TABLET;ORAL 091471 ANDA REMEDYREPACK INC. 70518-1013 70518-1013-0 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-1013-0)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Feb 17, 2016TE:ABRLD:No

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