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Generated: November 13, 2018

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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 forty-one drug master file entries for this compound. Nineteen 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
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
TAXOTERE docetaxel 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
TAXOTERE docetaxel 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

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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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 020449-001 May 14, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-003 Aug 3, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-003 Aug 3, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-001 May 14, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Sanofi Aventis Us TAXOTERE docetaxel INJECTABLE;INJECTION 020449-004 Aug 2, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Boehringer Ingelheim
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