Last Updated: November 8, 2026

Details for New Drug Application (NDA): 090092

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NDA 090092 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 090092

Tradename:	ZIDOVUDINE
Applicant:	Hetero Labs Ltd Iii
Ingredient:	zidovudine
Patents:	0

Pharmacology for NDA: 090092

Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

Medical Subject Heading (MeSH) Categories for 090092

Anti-HIV Agents
Antimetabolites
Reverse Transcriptase Inhibitors

Suppliers and Packaging for NDA: 090092

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZIDOVUDINE	zidovudine	TABLET;ORAL	090092	ANDA	Camber Pharmaceuticals, Inc.	31722-509	31722-509-60	12 BOTTLE in 1 CASE (31722-509-60) / 60 TABLET in 1 BOTTLE
ZIDOVUDINE	zidovudine	TABLET;ORAL	090092	ANDA	Coupler LLC	67046-1613	67046-1613-3	30 TABLET in 1 BLISTER PACK (67046-1613-3)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	300MG
Approval Date:	Apr 25, 2008	TE:	AB	RLD:	No

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