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Last Updated: January 29, 2026

Details for New Drug Application (NDA): 209634


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NDA 209634 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 209634
Tradename:DOCETAXEL
Applicant:Meitheal
Ingredient:docetaxel
Patents:0
Pharmacology for NDA: 209634
Physiological EffectMicrotubule Inhibition
Suppliers and Packaging for NDA: 209634
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOCETAXEL docetaxel INJECTABLE;INJECTION 209634 ANDA Meitheal Pharmaceuticals Inc 71288-144 71288-144-08 1 VIAL, MULTI-DOSE in 1 CARTON (71288-144-08) / 8 mL in 1 VIAL, MULTI-DOSE
DOCETAXEL docetaxel INJECTABLE;INJECTION 209634 ANDA Meitheal Pharmaceuticals Inc 71288-144 71288-144-16 1 VIAL, MULTI-DOSE in 1 CARTON (71288-144-16) / 16 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20MG/2ML (10MG/ML)
Approval Date:Aug 24, 2018TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength80MG/8ML (10MG/ML)
Approval Date:Aug 24, 2018TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength160MG/16ML (10MG/ML)
Approval Date:Aug 24, 2018TE:APRLD:No

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Preferred Citation:

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