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Last Updated: November 8, 2024

Details for New Drug Application (NDA): 090094


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NDA 090094 describes DIDANOSINE, which is a drug marketed by Aurobindo Pharma, Barr, Norvium Bioscience, and Aurobindo, and is included in five NDAs. 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. Additional details are available on the didanosine profile page.
Summary for 090094
Tradename:DIDANOSINE
Applicant:Aurobindo Pharma
Ingredient:didanosine
Patents:0
Medical Subject Heading (MeSH) Categories for 090094

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength125MG
Approval Date:Sep 24, 2008TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength200MG
Approval Date:Sep 24, 2008TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, DELAYED REL PELLETS;ORALStrength250MG
Approval Date:Sep 24, 2008TE:RLD:No

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