Last Updated: September 28, 2026

Details for New Drug Application (NDA): 020518

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NDA 020518 describes RETROVIR, which is a drug marketed by Viiv Hlthcare and is included in four NDAs. It is available from one supplier. Additional details are available on the RETROVIR profile page.

The generic ingredient in RETROVIR 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 020518

Tradename:	RETROVIR
Applicant:	Viiv Hlthcare
Ingredient:	zidovudine
Patents:	0

Medical Subject Heading (MeSH) Categories for 020518

Anti-HIV Agents
Antimetabolites
Reverse Transcriptase Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Dec 19, 1995	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Oct 4, 1996	TE:		RLD:	Yes

Expired US Patents for NDA 020518

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	RETROVIR	zidovudine	TABLET;ORAL	020518-002	Oct 4, 1996	4,833,130	⤷ Start Trial
Viiv Hlthcare	RETROVIR	zidovudine	TABLET;ORAL	020518-001	Dec 19, 1995	4,837,208	⤷ Start Trial
Viiv Hlthcare	RETROVIR	zidovudine	TABLET;ORAL	020518-001	Dec 19, 1995	4,724,232	⤷ Start Trial
Viiv Hlthcare	RETROVIR	zidovudine	TABLET;ORAL	020518-002	Oct 4, 1996	4,837,208	⤷ Start Trial
Viiv Hlthcare	RETROVIR	zidovudine	TABLET;ORAL	020518-001	Dec 19, 1995	4,833,130	⤷ Start Trial
Viiv Hlthcare	RETROVIR	zidovudine	TABLET;ORAL	020518-001	Dec 19, 1995	4,828,838	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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