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Last Updated: December 14, 2025

Details for New Drug Application (NDA): 019951

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NDA 019951 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 are twenty-two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the zidovudine profile page.

Summary for 019951

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

Pharmacology for NDA: 019951

Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

Medical Subject Heading (MeSH) Categories for 019951

Anti-HIV Agents
Antimetabolites
Reverse Transcriptase Inhibitors

Suppliers and Packaging for NDA: 019951

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RETROVIR	zidovudine	INJECTABLE;INJECTION	019951	NDA	ViiV Healthcare Company	49702-213	49702-213-26	5 VIAL, SINGLE-USE in 1 CARTON (49702-213-26) / 20 mL in 1 VIAL, SINGLE-USE (49702-213-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	10MG/ML
Approval Date:	Feb 2, 1990	TE:		RLD:	Yes

Expired US Patents for NDA 019951

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	RETROVIR	zidovudine	INJECTABLE;INJECTION	019951-001	Feb 2, 1990	4,724,232	⤷ Get Started Free
Viiv Hlthcare	RETROVIR	zidovudine	INJECTABLE;INJECTION	019951-001	Feb 2, 1990	4,833,130	⤷ Get Started Free
Viiv Hlthcare	RETROVIR	zidovudine	INJECTABLE;INJECTION	019951-001	Feb 2, 1990	4,837,208	⤷ Get Started Free
Viiv Hlthcare	RETROVIR	zidovudine	INJECTABLE;INJECTION	019951-001	Feb 2, 1990	4,828,838	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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