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Last Updated: November 8, 2024

Details for New Drug Application (NDA): 078957

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NDA 078957 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 078957

Tradename:	STAVUDINE
Applicant:	Hetero Labs Ltd Iii
Ingredient:	stavudine
Patents:	0

Medical Subject Heading (MeSH) Categories for 078957

Anti-HIV Agents
Antimetabolites
Reverse Transcriptase Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	15MG
Approval Date:	Dec 29, 2008	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	20MG
Approval Date:	Dec 29, 2008	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	30MG
Approval Date:	Dec 29, 2008	TE:		RLD:	No

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