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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
US Army
Teva
Cantor Fitzgerald
Fish and Richardson
Novartis
Accenture
Colorcon
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AstraZeneca

Generated: November 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201195

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NDA 201195 describes DOCETAXEL, which is a drug marketed by Apotex Inc, Sandoz, Hospira Inc, Eagle Pharms, Actavis Llc, Jiangsu Hengrui Med, Pfizer Labs, Ingenus Pharms Llc, Dfb Oncology Ltd, Teva Pharms Usa, Dr Reddys Labs Ltd, and Accord Hlthcare, and is included in thirteen NDAs. It is available from thirteen 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. Fifteen suppliers are listed for this compound. Additional details are available on the docetaxel profile page.

Summary for 201195

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 201195

Physiological EffectMicrotubule Inhibition

Suppliers and Packaging for NDA: 201195

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DOCETAXEL
docetaxel
INJECTABLE;INJECTION 201195 NDA Northstar RxLLC 16714-465 16714-465-01 1 VIAL, MULTI-DOSE in 1 CARTON (16714-465-01) > 1 mL in 1 VIAL, MULTI-DOSE
DOCETAXEL
docetaxel
INJECTABLE;INJECTION 201195 NDA Northstar RxLLC 16714-500 16714-500-01 1 VIAL, MULTI-DOSE in 1 CARTON (16714-500-01) > 4 mL in 1 VIAL, MULTI-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20MG/0.5ML (40MG/ML)
Approval Date:Jun 8, 2011TE:RLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength80MG/2ML (40MG/ML)
Approval Date:Jun 8, 2011TE:RLD:Yes

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20MG/ML (20MG/ML)
Approval Date:Apr 20, 2012TE:APRLD:Yes


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Serving leading biopharmaceutical companies globally:

US Army
Teva
Fish and Richardson
QuintilesIMS
Johnson and Johnson
Queensland Health
Deloitte
Julphar
Dow
Cantor Fitzgerald

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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