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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 077981

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NDA 077981 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 are twenty-two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the zidovudine profile page.

Summary for 077981

Tradename:	ZIDOVUDINE
Applicant:	Cipla Ltd
Ingredient:	zidovudine
Patents:	0

Medical Subject Heading (MeSH) Categories for 077981

Anti-HIV Agents
Antimetabolites
Reverse Transcriptase Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	50MG/5ML
Approval Date:	Jun 26, 2008	TE:	AA	RLD:	No

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