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Serving 500+ biopharmaceutical companies globally:

US Army
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Generated: July 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022234

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NDA 022234 describes DOCETAXEL, which is a drug marketed by Apotex Inc, Sandoz, Hospira Inc, Eagle Pharms, Actavis Llc, Pfizer Labs, Jiangsu Hengrui Med, Dfb Oncology Ltd, Teva Pharms Usa, Dr Reddys Labs Ltd, and Accord Hlthcare, and is included in eleven NDAs. It is available from twelve suppliers. There are two patents protecting this drug. Additional details are available on the DOCETAXEL profile page.

The generic ingredient in DOCETAXEL is docetaxel. There are forty drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the docetaxel profile page.

Summary for NDA: 022234

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 022234

Physiological EffectMicrotubule Inhibition

Suppliers and Packaging for NDA: 022234

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOCETAXEL
docetaxel
INJECTABLE;INJECTION 022234 NDA Hospira, Inc. 0409-0201 0409-0201-02 1 VIAL, SINGLE-USE in 1 CARTON (0409-0201-02) > 2 mL in 1 VIAL, SINGLE-USE
DOCETAXEL
docetaxel
INJECTABLE;INJECTION 022234 NDA Hospira, Inc. 0409-0201 0409-0201-10 1 VIAL, MULTI-DOSE in 1 CARTON (0409-0201-10) > 8 mL in 1 VIAL, MULTI-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20MG/2ML (10MG/ML)
Approval Date:Mar 8, 2011TE:APRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength80MG/8ML (10MG/ML)
Approval Date:Mar 8, 2011TE:APRLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength160MG/16ML (10MG/ML)
Approval Date:Mar 8, 2011TE:APRLD:Yes


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Serving 500+ biopharmaceutical companies globally:

Mallinckrodt
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Queensland Health
QuintilesIMS
Harvard Business School
Dow
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Fuji
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