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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 022234


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NDA 022234 describes DOCETAXEL, which is a drug marketed by Accord Hlthcare, Actavis, Alembic, Amneal, Apotex Inc, Dfb Oncology Ltd, Dr Reddys, Eugia Pharma, Gland, Guangdong Sunho, Hengrui Pharma, Heritage, Hikma, Hospira Inc, Meitheal, Mylan Labs Ltd, Novast Labs, Pfizer Labs, Pharmobedient, Sandoz, Shilpa, Sun Pharm, and Teva Pharms Usa, and is included in twenty-eight NDAs. It is available from twenty-one suppliers. There are four patents protecting this drug. Additional details are available on the DOCETAXEL profile page.

The generic ingredient in DOCETAXEL is docetaxel. There are forty-one drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the docetaxel profile page.
Summary for 022234
Tradename:DOCETAXEL
Applicant:Hospira Inc
Ingredient:docetaxel
Patents:0
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. 0409-0016 0409-0016-01 1 VIAL, MULTI-DOSE in 1 CARTON (0409-0016-01) / 16 mL in 1 VIAL, MULTI-DOSE
DOCETAXEL docetaxel INJECTABLE;INJECTION 022234 NDA Hospira, Inc. 0409-0201 0409-0201-02 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0201-02) / 2 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

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

Profile for product number 002

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

Profile 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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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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