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Generated: February 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205934

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NDA 205934 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, Pfizer Labs, Sandoz, Teva Pharms Usa, and Eagle Pharms, and is included in fourteen NDAs. It is available from fourteen 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. Sixteen suppliers are listed for this compound. Additional details are available on the docetaxel profile page.
Summary for 205934
Tradename:DOCETAXEL
Applicant:Eagle Pharms
Ingredient:docetaxel
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 205934
Physiological EffectMicrotubule Inhibition
Suppliers and Packaging for NDA: 205934
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOCETAXEL docetaxel SOLUTION;IV (INFUSION) 205934 NDA Eagle Pharmaceuticals, Inc. 42367-121 N 42367-121-25
DOCETAXEL docetaxel SOLUTION;IV (INFUSION) 205934 NDA Eagle Pharmaceuticals, Inc. 42367-121 N 42367-121-29

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION)Strength20MG/ML (20MG/ML)
Approval Date:Dec 22, 2015TE:RLD:No
Patent:➤ Try a Free TrialPatent Expiration:Sep 30, 2033Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF ADMINISTERING AN ETHANOL-FREE TAXANE LIQUID NANODISPERSION FORMULATION TO A SUBJECT COMBINING THE FORMULATION WITH AN AQUEOUS MEDIUM TO PROVIDE AN ETHANOL-FREE TAXANE DILUTED SOLUTION
Patent:➤ Try a Free TrialPatent Expiration:Sep 30, 2033Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION)Strength80MG/4ML (20MG/ML)
Approval Date:Dec 22, 2015TE:RLD:No
Patent:➤ Try a Free TrialPatent Expiration:Sep 30, 2033Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF ADMINISTERING AN ETHANOL-FREE TAXANE LIQUID NANODISPERSION FORMULATION TO A SUBJECT COMBINING THE FORMULATION WITH AN AQUEOUS MEDIUM TO PROVIDE AN ETHANOL-FREE TAXANE DILUTED SOLUTION

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