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Generated: June 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201525

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NDA 201525 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 201525
Tradename:DOCETAXEL
Applicant:Sandoz
Ingredient:docetaxel
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 201525
Physiological EffectMicrotubule Inhibition
Suppliers and Packaging for NDA: 201525
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOCETAXEL docetaxel INJECTABLE;INJECTION 201525 NDA Baxter Healthcare Corporation 43066-001 N 43066-001-01
DOCETAXEL docetaxel INJECTABLE;INJECTION 201525 NDA Baxter Healthcare Corporation 43066-006 N 43066-006-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20MG/2ML (10MG/ML)
Approval Date:Jun 29, 2011TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength80MG/8ML (10MG/ML)
Approval Date:Jun 29, 2011TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength160MG/16ML (10MG/ML)
Approval Date:Jun 29, 2011TE:APRLD:No

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