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Serving leading biopharmaceutical companies globally:

Queensland Health
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Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077574

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NDA 077574 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 077574
Tradename:PACLITAXEL
Applicant:Fresenius Kabi Oncol
Ingredient:paclitaxel
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 077574
Physiological EffectMicrotubule Inhibition
Medical Subject Heading (MeSH) Categories for 077574
Suppliers and Packaging for NDA: 077574
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PACLITAXEL paclitaxel INJECTABLE;INJECTION 077574 ANDA Fresenius Kabi USA, LLC 63323-763 63323-763-50 1 VIAL, MULTI-DOSE in 1 CARTON (63323-763-50) > 50 mL in 1 VIAL, MULTI-DOSE
PACLITAXEL paclitaxel INJECTABLE;INJECTION 077574 ANDA Fresenius Kabi USA, LLC 63323-763 63323-763-16 1 VIAL, MULTI-DOSE in 1 CARTON (63323-763-16) > 16.7 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength6MG/ML
Approval Date:Nov 27, 2006TE:APRLD:No

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