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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Julphar
US Department of Justice
Argus Health
Accenture
Covington
Merck
Express Scripts
Johnson and Johnson
Mallinckrodt

Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078195

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NDA 078195 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 078195

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Medical Subject Heading (MeSH) Categories for 078195

Suppliers and Packaging for NDA: 078195

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NEVIRAPINE nevirapine TABLET;ORAL 078195 ANDA Amneal-Agila, LLC 53150-209 53150-209-06 60 TABLET in 1 BOTTLE (53150-209-06)
NEVIRAPINE nevirapine TABLET;ORAL 078195 ANDA Strides Shasun Limited 64380-709 64380-709-03 60 TABLET in 1 BOTTLE, PLASTIC (64380-709-03)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:May 22, 2012TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

McKesson
UBS
Julphar
Mallinckrodt
Fish and Richardson
Daiichi Sankyo
Colorcon
Dow
Medtronic
Moodys

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