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Generated: November 21, 2018

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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. Twelve 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 019951
Medical Subject Heading (MeSH) Categories for 019951
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 49702-213-05 10 VIAL, SINGLE-USE in 1 TRAY (49702-213-05) > 20 mL in 1 VIAL, SINGLE-USE (49702-213-01)
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:RXDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:Feb 2, 1990TE:APRLD:Yes

Expired US Patents for NDA 019951

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Viiv Hlthcare RETROVIR zidovudine INJECTABLE;INJECTION 019951-001 Feb 2, 1990 ➤ Try a Free Trial ➤ Try a Free Trial
Viiv Hlthcare RETROVIR zidovudine INJECTABLE;INJECTION 019951-001 Feb 2, 1990 ➤ Try a Free Trial ➤ Try a Free Trial
Viiv Hlthcare RETROVIR zidovudine INJECTABLE;INJECTION 019951-001 Feb 2, 1990 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Chubb
Dow
Fish and Richardson
Covington
Argus Health
Colorcon
Baxter
Accenture

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