Last Updated: September 28, 2026

Details for New Drug Application (NDA): 019910

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NDA 019910 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 019910

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

Pharmacology for NDA: 019910

Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

Medical Subject Heading (MeSH) Categories for 019910

Anti-HIV Agents
Antimetabolites
Reverse Transcriptase Inhibitors

Suppliers and Packaging for NDA: 019910

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RETROVIR	zidovudine	SOLUTION;ORAL	019910	NDA	ViiV Healthcare Company	49702-212	49702-212-48	240 mL in 1 BOTTLE (49702-212-48)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	50MG/5ML
Approval Date:	Sep 28, 1989	TE:	AA	RLD:	Yes

Expired US Patents for NDA 019910

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	RETROVIR	zidovudine	SOLUTION;ORAL	019910-001	Sep 28, 1989	4,724,232	⤷ Start Trial
Viiv Hlthcare	RETROVIR	zidovudine	SOLUTION;ORAL	019910-001	Sep 28, 1989	4,837,208	⤷ Start Trial
Viiv Hlthcare	RETROVIR	zidovudine	SOLUTION;ORAL	019910-001	Sep 28, 1989	4,833,130	⤷ Start Trial
Viiv Hlthcare	RETROVIR	zidovudine	SOLUTION;ORAL	019910-001	Sep 28, 1989	4,818,538	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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