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McKesson
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Daiichi Sankyo
Argus Health
Harvard Business School
Federal Trade Commission

Generated: February 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205258

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NDA 205258 describes NEVIRAPINE, which is a drug marketed by Aurobindo, Cipla Ltd, Alvogen Malta, Apotex Inc, Aurobindo Pharma Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Sandoz Inc, Tech Organized, Cipla, Hetero Labs Ltd Iii, Micro Labs Ltd, Mylan Labs, Prinston Inc, and Strides Pharma, and is included in twenty-two NDAs. It is available from seventeen suppliers. Additional details are available on the NEVIRAPINE profile page.

The generic ingredient in NEVIRAPINE is nevirapine. There are twenty drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the nevirapine profile page.
Summary for 205258
Tradename:NEVIRAPINE
Applicant:Apotex Inc
Ingredient:nevirapine
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 205258
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NEVIRAPINE nevirapine TABLET, EXTENDED RELEASE;ORAL 205258 ANDA Apotex Corp 60505-4058 N 60505-4058-0
NEVIRAPINE nevirapine TABLET, EXTENDED RELEASE;ORAL 205258 ANDA Apotex Corp 60505-4058 N 60505-4058-3

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength400MG
Approval Date:Apr 3, 2014TE:RLD:No

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