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Last Updated: December 22, 2024

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 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 020518
Tradename:RETROVIR
Applicant:Viiv Hlthcare
Ingredient:zidovudine
Patents:0
Medical Subject Heading (MeSH) Categories for 020518

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength200MG
Approval Date:Dec 19, 1995TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Oct 4, 1996TE:RLD:Yes

Expired US Patents for NDA 020518

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

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