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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 077268

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NDA 077268 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 077268

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

Pharmacology for NDA: 077268

Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

Medical Subject Heading (MeSH) Categories for 077268

Anti-HIV Agents
Antimetabolites
Reverse Transcriptase Inhibitors

Suppliers and Packaging for NDA: 077268

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZIDOVUDINE	zidovudine	SOLUTION;ORAL	077268	ANDA	Aurobindo Pharma Limited	65862-048	65862-048-24	240 mL in 1 BOTTLE (65862-048-24)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	50MG/5ML
Approval Date:	Sep 19, 2005	TE:	AA	RLD:	No

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