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Last Updated: April 19, 2024

Details for New Drug Application (NDA): 019655

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NDA 019655 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. Four suppliers are listed for this compound. Additional details are available on the zidovudine profile page.

Summary for 019655

Tradename:	RETROVIR
Applicant:	Viiv Hlthcare
Ingredient:	zidovudine
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 019655

Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

Medical Subject Heading (MeSH) Categories for 019655

Anti-HIV Agents
Antimetabolites
Reverse Transcriptase Inhibitors

Suppliers and Packaging for NDA: 019655

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
RETROVIR	zidovudine	CAPSULE;ORAL	019655	NDA	ViiV Healthcare Company	49702-211	49702-211-20	100 CAPSULE in 1 BOTTLE (49702-211-20)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	Mar 19, 1987	TE:	AB	RLD:	Yes

Expired US Patents for NDA 019655

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	RETROVIR	zidovudine	CAPSULE;ORAL	019655-001	Mar 19, 1987	⤷ Try a Trial	⤷ Try a Trial
Viiv Hlthcare	RETROVIR	zidovudine	CAPSULE;ORAL	019655-001	Mar 19, 1987	⤷ Try a Trial	⤷ Try a Trial
Viiv Hlthcare	RETROVIR	zidovudine	CAPSULE;ORAL	019655-001	Mar 19, 1987	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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