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Generated: December 11, 2017

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:1
Applicant:1
Ingredient:1
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 0555-0588-01 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (0555-0588-01)
DIDANOSINE didanosine CAPSULE, DELAYED REL PELLETS;ORAL 077167 ANDA Teva Pharmaceuticals USA, Inc. 0555-0589 0555-0589-01 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (0555-0589-01)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


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