Last Updated: September 28, 2026

Details for New Drug Application (NDA): 078922

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NDA 078922 describes ZIDOVUDINE, which is a drug marketed by Aurobindo Pharma Ltd, Cipla Ltd, Am Regent, Liaoning Chengda, Aurobindo, Aurobindo Pharma, Cipla, Hec Pharm, Hetero Labs Ltd Iii, Hikma, Pharmobedient, and Ranbaxy Labs Ltd, and is included in fifteen NDAs. It is available from three suppliers. Additional details are available on the ZIDOVUDINE profile page.

The generic ingredient in ZIDOVUDINE is zidovudine. There is one drug master file entry for this compound. Four suppliers are listed for this compound. Additional details are available on the zidovudine profile page.

Summary for 078922

Tradename:	ZIDOVUDINE
Applicant:	Pharmobedient
Ingredient:	zidovudine
Patents:	0

Medical Subject Heading (MeSH) Categories for 078922

Anti-HIV Agents
Antimetabolites
Reverse Transcriptase Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	300MG
Approval Date:	Feb 14, 2008	TE:		RLD:	No

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