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Last Updated: August 11, 2022

Details for New Drug Application (NDA): 020449


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NDA 020449 describes TAXOTERE, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from one supplier. Additional details are available on the TAXOTERE profile page.

The generic ingredient in TAXOTERE is docetaxel. There are forty-one drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the docetaxel profile page.
Summary for 020449
Tradename:TAXOTERE
Applicant:Sanofi Aventis Us
Ingredient:docetaxel
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 020449
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TAXOTERE docetaxel INJECTABLE;INJECTION 020449 NDA AUTHORIZED GENERIC Winthrop U.S. 0955-1020 0955-1020-01 1 VIAL, GLASS in 1 CARTON (0955-1020-01) > 1 mL in 1 VIAL, GLASS
TAXOTERE docetaxel INJECTABLE;INJECTION 020449 NDA AUTHORIZED GENERIC Winthrop U.S. 0955-1021 0955-1021-04 1 VIAL, GLASS in 1 CARTON (0955-1021-04) > 4 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:May 14, 1996TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20MG/ML (20MG/ML)
Approval Date:Aug 3, 2010TE:APRLD:Yes

Profile for product number 004

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength80MG/4ML (20MG/ML)
Approval Date:Aug 2, 2010TE:APRLD:Yes

Expired US Patents for NDA 020449

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-004 Aug 2, 2010 See Plans and Pricing See Plans and Pricing
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-004 Aug 2, 2010 See Plans and Pricing See Plans and Pricing
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-001 May 14, 1996 See Plans and Pricing See Plans and Pricing
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-003 Aug 3, 2010 See Plans and Pricing See Plans and Pricing
>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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