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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 020857

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NDA 020857 describes COMBIVIR, which is a drug marketed by Viiv Hlthcare and is included in one NDA. It is available from one supplier. Additional details are available on the COMBIVIR profile page.

The generic ingredient in COMBIVIR 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 020857

Tradename:	COMBIVIR
Applicant:	Viiv Hlthcare
Ingredient:	lamivudine; zidovudine
Patents:	0

Pharmacology for NDA: 020857

Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

Suppliers and Packaging for NDA: 020857

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
COMBIVIR	lamivudine; zidovudine	TABLET;ORAL	020857	NDA	ViiV Healthcare Company	49702-202	49702-202-18	60 TABLET, FILM COATED in 1 BOTTLE (49702-202-18)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	150MG;300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Sep 26, 1997	TE:		RLD:	Yes

Expired US Patents for NDA 020857

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	COMBIVIR	lamivudine; zidovudine	TABLET;ORAL	020857-001	Sep 26, 1997	⤷ Get Started Free	⤷ Get Started Free
Viiv Hlthcare	COMBIVIR	lamivudine; zidovudine	TABLET;ORAL	020857-001	Sep 26, 1997	⤷ Get Started Free	⤷ Get Started Free
Viiv Hlthcare	COMBIVIR	lamivudine; zidovudine	TABLET;ORAL	020857-001	Sep 26, 1997	⤷ Get Started Free	⤷ Get Started Free
Viiv Hlthcare	COMBIVIR	lamivudine; zidovudine	TABLET;ORAL	020857-001	Sep 26, 1997	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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