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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Healthtrust
Baxter
Mallinckrodt
US Department of Justice
Colorcon
US Army
Chubb
Accenture

Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076131

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NDA 076131 describes PACLITAXEL, which is a drug marketed by Accord Hlthcare, Actavis Totowa, Fresenius Kabi Oncol, Hospira, Mylan, Mylan Labs Ltd, Pliva Lachema, Sandoz Inc, Teva Pharms, Teva Pharms Usa, and West-ward Pharms Int, and is included in twelve NDAs. It is available from seven suppliers. Additional details are available on the PACLITAXEL profile page.

The generic ingredient in PACLITAXEL is paclitaxel. There are sixty-nine drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the paclitaxel profile page.
Summary for 076131
Tradename:PACLITAXEL
Applicant:Hospira
Ingredient:paclitaxel
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076131
Physiological EffectMicrotubule Inhibition
Medical Subject Heading (MeSH) Categories for 076131
Suppliers and Packaging for NDA: 076131
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PACLITAXEL paclitaxel INJECTABLE;INJECTION 076131 ANDA Hospira, Inc. 61703-342 N 61703-342-09
PACLITAXEL paclitaxel INJECTABLE;INJECTION 076131 ANDA Hospira, Inc. 61703-342 N 61703-342-22

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength6MG/ML
Approval Date:May 8, 2002TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Chinese Patent Office
QuintilesIMS
Cipla
Queensland Health
Merck
Teva
Johnson and Johnson
Federal Trade Commission

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