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Last Updated: November 13, 2019

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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 are twenty-two drug master file entries for this compound. Nine 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 019910
Medical Subject Heading (MeSH) Categories for 019910
Suppliers and Packaging for NDA: 019910
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RETROVIR zidovudine SYRUP;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:RXDosage:SYRUP;ORALStrength50MG/5ML
Approval Date:Sep 28, 1989TE:AARLD:Yes

Expired US Patents for NDA 019910

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Viiv Hlthcare RETROVIR zidovudine SYRUP;ORAL 019910-001 Sep 28, 1989   Start Trial   Start Trial
Viiv Hlthcare RETROVIR zidovudine SYRUP;ORAL 019910-001 Sep 28, 1989   Start Trial   Start Trial
Viiv Hlthcare RETROVIR zidovudine SYRUP;ORAL 019910-001 Sep 28, 1989   Start Trial   Start Trial
Viiv Hlthcare RETROVIR zidovudine SYRUP;ORAL 019910-001 Sep 28, 1989   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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