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Last Updated: April 16, 2026

Details for New Drug Application (NDA): 077774

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NDA 077774 describes STAVUDINE, which is a drug marketed by Aurobindo Pharma, Hetero Labs Ltd Iii, Pharmobedient, and Cipla Ltd, and is included in six NDAs. Additional details are available on the STAVUDINE profile page.

The generic ingredient in STAVUDINE is stavudine. There are fourteen drug master file entries for this compound. Additional details are available on the stavudine profile page.

Summary for 077774

Tradename:	STAVUDINE
Applicant:	Aurobindo Pharma
Ingredient:	stavudine
Patents:	0

Medical Subject Heading (MeSH) Categories for 077774

Anti-HIV Agents
Antimetabolites
Reverse Transcriptase Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FOR SOLUTION;ORAL			Strength	1MG/ML
Approval Date:	Dec 29, 2008	TE:		RLD:	No

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