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Chinese Patent Office
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Generated: June 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203551

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NDA 203551 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 203551
Tradename:DOCETAXEL
Applicant:Actavis Llc
Ingredient:docetaxel
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203551
Physiological EffectMicrotubule Inhibition
Suppliers and Packaging for NDA: 203551
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOCETAXEL docetaxel INJECTABLE;INJECTION 203551 NDA Actavis Pharma, Inc. 45963-734 N 45963-734-54
DOCETAXEL docetaxel INJECTABLE;INJECTION 203551 NDA Actavis Pharma, Inc. 45963-765 N 45963-765-52

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20MG/ML (20MG/ML)
Approval Date:Apr 12, 2013TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength80MG/4ML (20MG/ML)
Approval Date:Apr 12, 2013TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength140MG/7ML (20MG/ML)
Approval Date:Apr 12, 2013TE:RLD:No

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