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Generated: February 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090130

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NDA 090130 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 eight suppliers. Additional details are available on the PACLITAXEL profile page.

The generic ingredient in PACLITAXEL is paclitaxel. There are sixty-eight drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the paclitaxel profile page.
Summary for 090130
Tradename:PACLITAXEL
Applicant:Actavis Totowa
Ingredient:paclitaxel
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 090130
Physiological EffectMicrotubule Inhibition
Medical Subject Heading (MeSH) Categories for 090130
Suppliers and Packaging for NDA: 090130
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PACLITAXEL paclitaxel INJECTABLE;INJECTION 090130 ANDA Sagent Pharmaceuticals 25021-213 N 25021-213-05
PACLITAXEL paclitaxel INJECTABLE;INJECTION 090130 ANDA Sagent Pharmaceuticals 25021-213 N 25021-213-17

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength6MG/ML
Approval Date:Dec 9, 2009TE:APRLD:No

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