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Generated: September 20, 2018

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Details for New Drug Application (NDA): 091540

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NDA 091540 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 thirteen 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 091540
Tradename:PACLITAXEL
Applicant:Mylan Labs Ltd
Ingredient:paclitaxel
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 091540
Physiological EffectMicrotubule Inhibition
Medical Subject Heading (MeSH) Categories for 091540
Suppliers and Packaging for NDA: 091540
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PACLITAXEL paclitaxel INJECTABLE;INJECTION 091540 ANDA Mylan Institutional LLC 67457-434 67457-434-51 1 VIAL in 1 CARTON (67457-434-51) > 50 mL in 1 VIAL
PACLITAXEL paclitaxel INJECTABLE;INJECTION 091540 ANDA Mylan Institutional LLC 67457-449 67457-449-17 1 VIAL in 1 CARTON (67457-449-17) > 16.7 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength6MG/ML
Approval Date:Sep 29, 2011TE:APRLD:No

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