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Last Updated: December 26, 2024

Details for New Drug Application (NDA): 078775

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NDA 078775 describes STAVUDINE, which is a drug marketed by Aurobindo Pharma, Hetero Labs Ltd Iii, Norvium Bioscience, 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 078775

Tradename:	STAVUDINE
Applicant:	Norvium Bioscience
Ingredient:	stavudine
Patents:	0

Medical Subject Heading (MeSH) Categories for 078775

Anti-HIV Agents
Antimetabolites
Reverse Transcriptase Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	30MG
Approval Date:	Jan 5, 2009	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	40MG
Approval Date:	Jan 5, 2009	TE:		RLD:	No

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