Last Updated: September 28, 2026

Details for New Drug Application (NDA): 078128

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NDA 078128 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 078128

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

Pharmacology for NDA: 078128

Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

Medical Subject Heading (MeSH) Categories for 078128

Anti-HIV Agents
Antimetabolites
Reverse Transcriptase Inhibitors

Suppliers and Packaging for NDA: 078128

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZIDOVUDINE	zidovudine	CAPSULE;ORAL	078128	ANDA	Aurobindo Pharma Limited	65862-107	65862-107-01	100 CAPSULE in 1 BOTTLE (65862-107-01)
ZIDOVUDINE	zidovudine	CAPSULE;ORAL	078128	ANDA	Aurobindo Pharma Limited	65862-107	65862-107-10	10 BLISTER PACK in 1 CARTON (65862-107-10) / 10 CAPSULE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	Mar 27, 2006	TE:	AB	RLD:	No

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