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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 090561

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NDA 090561 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 two 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. Three suppliers are listed for this compound. Additional details are available on the zidovudine profile page.

Summary for 090561

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

Medical Subject Heading (MeSH) Categories for 090561

Anti-HIV Agents
Antimetabolites
Reverse Transcriptase Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	300MG
Approval Date:	Oct 27, 2010	TE:	AB	RLD:	No

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