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Last Updated: November 6, 2025

Details for New Drug Application (NDA): 090679

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NDA 090679 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, and Pharmacare, 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 090679

Tradename:	LAMIVUDINE AND ZIDOVUDINE
Applicant:	Macleods Pharms Ltd
Ingredient:	lamivudine; zidovudine
Patents:	0

Pharmacology for NDA: 090679

Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

Suppliers and Packaging for NDA: 090679

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LAMIVUDINE AND ZIDOVUDINE	lamivudine; zidovudine	TABLET;ORAL	090679	ANDA	Macleods Pharmaceuticals Limited	33342-003	33342-003-09	60 TABLET in 1 BOTTLE (33342-003-09)
LAMIVUDINE AND ZIDOVUDINE	lamivudine; zidovudine	TABLET;ORAL	090679	ANDA	Bryant Ranch Prepack	71335-1916	71335-1916-1	6 TABLET in 1 BOTTLE (71335-1916-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	150MG;300MG
Approval Date:	Aug 29, 2018	TE:	AB	RLD:	No

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