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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 078112

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NDA 078112 describes DIDANOSINE, which is a drug marketed by Aurobindo Pharma, Barr, Pharmobedient, 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 078112

Tradename:	DIDANOSINE
Applicant:	Aurobindo Pharma
Ingredient:	didanosine
Patents:	0

Medical Subject Heading (MeSH) Categories for 078112

Anti-HIV Agents
Antimetabolites
Reverse Transcriptase Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FOR SOLUTION;ORAL			Strength	10MG/ML
Approval Date:	Mar 8, 2007	TE:		RLD:	No

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