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US Army
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Generated: April 22, 2018

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, Mylan Pharms Inc, and Strides Pharma, and is included in three NDAs. It is available from five suppliers. Additional details are available on the EFAVIRENZ profile page.

The generic ingredient in EFAVIRENZ is efavirenz. There are twenty-six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the efavirenz profile page.
Summary for 091471
Applicant:Mylan Pharms Inc
Therapeutic Class:Antivirals
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 N 0378-2233-93
EFAVIRENZ efavirenz TABLET;ORAL 091471 ANDA REMEDYREPACK INC. 70518-1013 N 70518-1013-0

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Feb 17, 2016TE:ABRLD:No
Regulatory Exclusivity Expiration:Feb 14, 2018
Regulatory Exclusivity Use:PATENT CHALLENGE

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Fish and Richardson
Chinese Patent Office

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