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Last Updated: March 31, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077673

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NDA 077673 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 077673
Applicant:Aurobindo Pharma Ltd
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 077673
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EFAVIRENZ efavirenz TABLET;ORAL 077673 ANDA Aurobindo Pharma Limited 65862-049 65862-049-10 3 BLISTER PACK in 1 CARTON (65862-049-10) > 10 TABLET, FILM COATED in 1 BLISTER PACK
EFAVIRENZ efavirenz TABLET;ORAL 077673 ANDA Aurobindo Pharma Limited 65862-049 65862-049-30 30 TABLET, FILM COATED in 1 BOTTLE (65862-049-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Sep 21, 2018TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
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