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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
US Department of Justice
Fish and Richardson
Merck
Julphar
Colorcon
Medtronic
US Army
Express Scripts

Generated: June 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077167

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NDA 077167 describes DIDANOSINE, which is a drug marketed by Aurobindo Pharma, Barr, Mylan Pharms Inc, and Aurobindo, and is included in five NDAs. It is available from four suppliers. Additional details are available on the DIDANOSINE profile page.

The generic ingredient in DIDANOSINE is didanosine. There are eight drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the didanosine profile page.
Summary for 077167
Tradename:DIDANOSINE
Applicant:Barr
Ingredient:didanosine
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 077167
Medical Subject Heading (MeSH) Categories for 077167
Suppliers and Packaging for NDA: 077167
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIDANOSINE didanosine CAPSULE, DELAYED REL PELLETS;ORAL 077167 ANDA Teva Pharmaceuticals USA, Inc. 0555-0588 N 0555-0588-01
DIDANOSINE didanosine CAPSULE, DELAYED REL PELLETS;ORAL 077167 ANDA Teva Pharmaceuticals USA, Inc. 0555-0589 N 0555-0589-01

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength200MG
Approval Date:Dec 3, 2004TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength250MG
Approval Date:Dec 3, 2004TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength400MG
Approval Date:Dec 3, 2004TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Julphar
Teva
McKinsey
Daiichi Sankyo
Fuji
Merck
McKesson
Medtronic

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