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Last Updated: March 28, 2026

Details for New Drug Application (NDA): 204193


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NDA 204193 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 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-four suppliers are listed for this compound. Additional details are available on the docetaxel profile page.
Summary for 204193
Tradename:DOCETAXEL
Applicant:Dr Reddys
Ingredient:docetaxel
Patents:0
Pharmacology for NDA: 204193
Physiological EffectMicrotubule Inhibition
Suppliers and Packaging for NDA: 204193
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOCETAXEL docetaxel INJECTABLE;INJECTION 204193 ANDA Dr. Reddy's Laboratories Inc. 43598-258 43598-258-11 1 mL in 1 VIAL, GLASS (43598-258-11)
DOCETAXEL docetaxel INJECTABLE;INJECTION 204193 ANDA Dr. Reddy's Laboratories Inc. 43598-259 43598-259-40 4 mL in 1 VIAL, GLASS (43598-259-40)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20MG/ML (20MG/ML)
Approval Date:Nov 5, 2014TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength80MG/4ML (20MG/ML)
Approval Date:Nov 5, 2014TE:APRLD:No

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Preferred Citation:

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