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Last Updated: February 16, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078064

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NDA 078064 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 078064
Applicant:Aurobindo Pharma Ltd
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 078064
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EFAVIRENZ efavirenz CAPSULE;ORAL 078064 ANDA Rising Pharmaceuticals, Inc. 64980-406 64980-406-03 30 CAPSULE in 1 BOTTLE (64980-406-03)
EFAVIRENZ efavirenz CAPSULE;ORAL 078064 ANDA Rising Pharmaceuticals, Inc. 64980-407 64980-407-09 90 CAPSULE in 1 BOTTLE (64980-407-09)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Dec 15, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Dec 15, 2017TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Dec 15, 2017TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

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