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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 two suppliers. Additional details are available on the TAXOTERE profile page.

The generic ingredient in TAXOTERE is docetaxel. There are thirty-nine drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the docetaxel profile page.

Summary for NDA: 020449

Sanofi Aventis Us
Formulation / Manufacturing:see details

Pharmacology for NDA: 020449

Physiological EffectMicrotubule Inhibition

Suppliers and Packaging for NDA: 020449

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
INJECTABLE;INJECTION 020449 NDA sanofi-aventis U.S. LLC 0075-8003 0075-8003-01 1 VIAL, GLASS in 1 CARTON (0075-8003-01) > 1 mL in 1 VIAL, GLASS
INJECTABLE;INJECTION 020449 NDA sanofi-aventis U.S. LLC 0075-8004 0075-8004-04 1 VIAL, GLASS in 1 CARTON (0075-8004-04) > 4 mL in 1 VIAL, GLASS

Summary 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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:May 14, 1996TE:RLD:No

Summary for product number 003

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

Summary for product number 004

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

Expired Orange Book Patents for NDA: 020449

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us
INJECTABLE;INJECTION020449-001May 14, 19964,814,470*PED► subscribe
Sanofi Aventis Us
INJECTABLE;INJECTION020449-004Aug 2, 20104,814,470*PED► subscribe
Sanofi Aventis Us
INJECTABLE;INJECTION020449-003Aug 3, 20104,814,470*PED► subscribe
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