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Serving leading biopharmaceutical companies globally:

Citi
Daiichi Sankyo
AstraZeneca
US Department of Justice
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QuintilesIMS
Chubb
Julphar
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Generated: November 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077574

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NDA 077574 describes PACLITAXEL, which is a drug marketed by Pliva Lachema, Actavis Totowa, Hospira, Accord Hlthcare, Mylan Labs Ltd, Sandoz Inc, Fresenius Kabi Oncol, Mylan, Teva Pharms, West-ward Pharms Int, and Teva Pharms Usa, and is included in twelve NDAs. It is available from eight suppliers. Additional details are available on the PACLITAXEL profile page.

The generic ingredient in PACLITAXEL is paclitaxel. There are sixty-seven drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the paclitaxel profile page.

Summary for 077574

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

Pharmacology for NDA: 077574

Physiological EffectMicrotubule Inhibition

Medical Subject Heading (MeSH) Categories for 077574

Suppliers and Packaging for NDA: 077574

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PACLITAXEL
paclitaxel
INJECTABLE;INJECTION 077574 ANDA Fresenius Kabi USA, LLC 63323-763 63323-763-05 1 VIAL, MULTI-DOSE in 1 CARTON (63323-763-05) > 5 mL in 1 VIAL, MULTI-DOSE
PACLITAXEL
paclitaxel
INJECTABLE;INJECTION 077574 ANDA Fresenius Kabi USA, LLC 63323-763 63323-763-16 1 VIAL, MULTI-DOSE in 1 CARTON (63323-763-16) > 16.7 mL in 1 VIAL, MULTI-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength6MG/ML
Approval Date:Nov 27, 2006TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Julphar
Harvard Business School
Farmers Insurance
Argus Health
Chinese Patent Office
Medtronic
Cipla
Daiichi Sankyo
Deloitte

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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