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Generated: August 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205934

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NDA 205934 describes DOCETAXEL, which is a drug marketed by Apotex Inc, Sandoz, Hospira Inc, Eagle Pharms, Actavis Llc, Pfizer Labs, Jiangsu Hengrui Med, Dfb Oncology Ltd, Teva Pharms Usa, Dr Reddys Labs Ltd, and Accord Hlthcare, and is included in eleven NDAs. It is available from twelve 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. Fourteen suppliers are listed for this compound. Additional details are available on the docetaxel profile page.

Summary for NDA: 205934

Tradename:
1
Applicant:
1
Ingredient:
1
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 42367-121-21 1 VIAL, SINGLE-DOSE in 1 CARTON (42367-121-21) > 1 mL in 1 VIAL, SINGLE-DOSE
DOCETAXEL
docetaxel
SOLUTION;IV (INFUSION) 205934 NDA Eagle Pharmaceuticals, Inc. 42367-121 42367-121-25 1 VIAL, MULTI-DOSE in 1 CARTON (42367-121-25) > 4 mL in 1 VIAL, MULTI-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION)Strength20MG/ML (20MG/ML)
Approval Date:Dec 22, 2015TE:RLD:No
Patent:► SubscribePatent Expiration:Sep 30, 2033Product Flag?YSubstance Flag?Delist Request?
Patent:► SubscribePatent 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

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION)Strength80MG/4ML (20MG/ML)
Approval Date:Dec 22, 2015TE:RLD:No
Patent:► SubscribePatent Expiration:Sep 30, 2033Product Flag?YSubstance Flag?Delist Request?


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Serving 500+ biopharmaceutical companies globally:

Argus Health
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QuintilesIMS
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US Department of Justice
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Daiichi Sankyo

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