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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. Sixteen suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the zidovudine profile page.

Summary for NDA: 019910

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

Pharmacology for NDA: 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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength50MG/5ML
Approval Date:Sep 28, 1989TE:AARLD:Yes

Expired Orange Book Patents for NDA: 019910

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Viiv Hlthcare
RETROVIR
zidovudine
SYRUP;ORAL019910-001Sep 28, 19894,724,232► subscribe
Viiv Hlthcare
RETROVIR
zidovudine
SYRUP;ORAL019910-001Sep 28, 19894,837,208► subscribe
Viiv Hlthcare
RETROVIR
zidovudine
SYRUP;ORAL019910-001Sep 28, 19894,833,130► subscribe
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