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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Johnson and Johnson
US Army
Chinese Patent Office
Queensland Health

Generated: June 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204193

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NDA 204193 describes DOCETAXEL, which is a drug marketed by Accord Hlthcare, Actavis Llc, Amneal Pharms Co, Apotex Inc, Dfb Oncology Ltd, Dr Reddys Labs Ltd, Hospira Inc, Ingenus Pharms Llc, Jiangsu Hengrui Med, Mylan Labs Ltd, Pfizer Labs, Sandoz, Teva Pharms Usa, and Eagle Pharms, and is included in fifteen NDAs. It is available from fifteen 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. Seventeen suppliers are listed for this compound. Additional details are available on the docetaxel profile page.
Summary for 204193
Applicant:Dr Reddys Labs Ltd
Formulation / Manufacturing:see details
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 N 43598-258-11
DOCETAXEL docetaxel INJECTABLE;INJECTION 204193 ANDA Dr. Reddy's Laboratories Inc. 43598-259 N 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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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Harvard Business School

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