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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Merck
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McKesson
Julphar
Novartis
Cantor Fitzgerald
Daiichi Sankyo
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Generated: January 21, 2018

DrugPatentWatch Database Preview

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 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 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 Pfizer Laboratories Div Pfizer Inc. 0069-0076 0069-0076-01 16.7 mL in 1 VIAL (0069-0076-01)
PACLITAXEL paclitaxel INJECTABLE;INJECTION 091540 ANDA Pfizer Laboratories Div Pfizer Inc. 0069-0078 0069-0078-01 50 mL in 1 VIAL (0069-0078-01)

Profile for product number 001

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

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Serving leading biopharmaceutical companies globally:

Baxter
Argus Health
Novartis
Dow
Fish and Richardson
Express Scripts
Cerilliant
US Army
Colorcon

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