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Generated: September 25, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078818

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NDA 078818 describes OXALIPLATIN, which is a drug marketed by Actavis Totowa, Fresenius Kabi Oncol, Sandoz Inc, Hospira Worldwide, Hospira Inc, Qilu Pharm Co Ltd, Sandoz, Sun Pharma Global, Fresenius Kabi Usa, Cipla Ltd, Gland Pharma Ltd, Sanja Pharms Co, Mylan Labs Ltd, Teva Pharms, Jiangsu Hengrui Med, Accord Hlthcare, and Luitpold Pharms Inc, and is included in twenty-four NDAs. It is available from eighteen suppliers. Additional details are available on the OXALIPLATIN profile page.

The generic ingredient in OXALIPLATIN is oxaliplatin. There are twenty-six drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the oxaliplatin profile page.

Summary for NDA: 078818

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

Pharmacology for NDA: 078818

Suppliers and Packaging for NDA: 078818

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXALIPLATIN
oxaliplatin
INJECTABLE;IV (INFUSION) 078818 ANDA Sun Pharma Global FZE 47335-176 47335-176-40 1 VIAL, SINGLE-USE in 1 CARTON (47335-176-40) > 10 mL in 1 VIAL, SINGLE-USE
OXALIPLATIN
oxaliplatin
INJECTABLE;IV (INFUSION) 078818 ANDA Sun Pharma Global FZE 47335-178 47335-178-40 1 VIAL, SINGLE-USE in 1 CARTON (47335-178-40) > 20 mL in 1 VIAL, SINGLE-USE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength50MG/VIAL
Approval Date:Aug 7, 2009TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength100MG/VIAL
Approval Date:Aug 7, 2009TE:APRLD:No


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Serving 500+ biopharmaceutical companies globally:

Accenture
Chubb
Cantor Fitzgerald
US Army
Boehringer Ingelheim
Moodys
US Department of Justice
AstraZeneca
Dow
Colorcon

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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