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Last Updated: December 14, 2025

Details for New Drug Application (NDA): 077267

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NDA 077267 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 077267

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

Pharmacology for NDA: 077267

Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

Medical Subject Heading (MeSH) Categories for 077267

Anti-HIV Agents
Antimetabolites
Reverse Transcriptase Inhibitors

Suppliers and Packaging for NDA: 077267

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZIDOVUDINE	zidovudine	TABLET;ORAL	077267	ANDA	Aurobindo Pharma Limited	65862-024	65862-024-10	6 BLISTER PACK in 1 CARTON (65862-024-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
ZIDOVUDINE	zidovudine	TABLET;ORAL	077267	ANDA	Aurobindo Pharma Limited	65862-024	65862-024-60	60 TABLET, FILM COATED in 1 BOTTLE (65862-024-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	300MG
Approval Date:	Sep 19, 2005	TE:	AB	RLD:	No

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