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Generated: June 27, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091358

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NDA 091358 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, Mylan Labs Ltd, Teva Pharms, Jiangsu Hengrui Med, Accord Hlthcare, and Luitpold Pharms Inc, and is included in twenty-three NDAs. It is available from sixteen 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. Nineteen suppliers are listed for this compound. Additional details are available on the oxaliplatin profile page.

Summary for NDA: 091358

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

Pharmacology for NDA: 091358

Suppliers and Packaging for NDA: 091358

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXALIPLATIN
oxaliplatin
INJECTABLE;IV (INFUSION) 091358 ANDA Pfizer Laboratories Div Pfizer Inc. 0069-0070 0069-0070-01 20 mL in 1 VIAL (0069-0070-01)
OXALIPLATIN
oxaliplatin
INJECTABLE;IV (INFUSION) 091358 ANDA Pfizer Laboratories Div Pfizer Inc. 0069-0074 0069-0074-01 10 mL in 1 VIAL (0069-0074-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength50MG/10ML (5MG/ML)
Approval Date:Aug 7, 2012TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength100MG/20ML (5MG/ML)
Approval Date:Aug 7, 2012TE:APRLD:No


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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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