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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 203259

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NDA 203259 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 203259

Tradename:	LAMIVUDINE AND ZIDOVUDINE
Applicant:	Hetero Labs Ltd V
Ingredient:	lamivudine; zidovudine
Patents:	0

Pharmacology for NDA: 203259

Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

Suppliers and Packaging for NDA: 203259

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LAMIVUDINE AND ZIDOVUDINE	lamivudine; zidovudine	TABLET;ORAL	203259	ANDA	Camber Pharmaceuticals, Inc.	31722-739	31722-739-05	500 TABLET, FILM COATED in 1 BOTTLE (31722-739-05)
LAMIVUDINE AND ZIDOVUDINE	lamivudine; zidovudine	TABLET;ORAL	203259	ANDA	Camber Pharmaceuticals, Inc.	31722-739	31722-739-31	100 TABLET, FILM COATED in 1 BLISTER PACK (31722-739-31)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	150MG;300MG
Approval Date:	Feb 3, 2014	TE:	AB	RLD:	No

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