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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 079081

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NDA 079081 describes LAMIVUDINE AND ZIDOVUDINE, which is a drug marketed by Aurobindo Pharma, Aurobindo Pharma Ltd, Chartwell Rx, Cipla, Epic Pharma Llc, Hetero Labs Ltd Iii, Hetero Labs Ltd V, Lupin Ltd, Macleods Pharms Ltd, Natco, Norvium Bioscience, Pharmacare, and Pharmobedient, and is included in thirteen NDAs. It is available from seven suppliers. Additional details are available on the LAMIVUDINE AND ZIDOVUDINE profile page.

The generic ingredient in LAMIVUDINE AND ZIDOVUDINE is lamivudine; zidovudine. There are twenty-nine drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the lamivudine; zidovudine profile page.

Summary for 079081

Tradename:	LAMIVUDINE AND ZIDOVUDINE
Applicant:	Chartwell Rx
Ingredient:	lamivudine; zidovudine
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	150MG;300MG
Approval Date:	May 25, 2011	TE:		RLD:	No

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