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Generated: September 19, 2018

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Details for New Drug Application (NDA): 202356

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NDA 202356 describes DOCETAXEL, which is a drug marketed by Accord Hlthcare, Actavis Llc, Amneal Pharms Co, Apotex Inc, Cipla Ltd, Dfb Oncology Ltd, Dr Reddys Labs Ltd, Eagle Pharms, Hospira Inc, Ingenus Pharms Llc, Jiangsu Hengrui Med, Mylan Labs Ltd, Pfizer Labs, Sandoz, and Teva Pharms Usa, and is included in eighteen NDAs. It is available from seventeen 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. Nineteen suppliers are listed for this compound. Additional details are available on the docetaxel profile page.
Summary for 202356
Tradename:DOCETAXEL
Applicant:Pfizer Labs
Ingredient:docetaxel
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength20MG/2ML (10MG/ML)
Approval Date:Mar 13, 2014TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength80MG/8ML (10MG/ML)
Approval Date:Mar 13, 2014TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength130MG/13ML (10MG/ML)
Approval Date:Mar 13, 2014TE:RLD:No

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