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TAXOTERE Drug Profile

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Taxotere is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from two suppliers.

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 Tradename: TAXOTERE

Patents:0
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Drug Prices: :see details

Pharmacology for Tradename: TAXOTERE

Drug ClassMicrotubule Inhibitor
Physiological EffectMicrotubule Inhibition

Clinical Trials for: TAXOTERE

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us
TAXOTERE
docetaxel
INJECTABLE;INJECTION020449-003Aug 3, 2010RXYes
Sanofi Aventis Us
TAXOTERE
docetaxel
INJECTABLE;INJECTION020449-005Apr 13, 2012RXYes
Sanofi Aventis Us
TAXOTERE
docetaxel
INJECTABLE;INJECTION020449-001May 14, 1996DISCNNo
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Expired Patents for Tradename: TAXOTERE

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us
TAXOTERE
docetaxel
INJECTABLE;INJECTION020449-003Aug 3, 20104,814,470*PED<disabled>
Sanofi Aventis Us
TAXOTERE
docetaxel
INJECTABLE;INJECTION020449-001May 14, 19964,814,470*PED<disabled>
Sanofi Aventis Us
TAXOTERE
docetaxel
INJECTABLE;INJECTION020449-004Aug 2, 20105,714,512*PED<disabled>
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Paragraph IV activity for: TAXOTERE

Drugname Dosage Strength RLD Submissiondate
docetaxelInjection40 mg/mL, 0.5 mL and 2 mL vialsTaxotere6/30/2009
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