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Details for New Drug Application (NDA): 200979

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NDA 200979 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, and Jiangsu Hengrui Med, and is included in twenty NDAs. It is available from fourteen 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. Seventeen suppliers are listed for this compound. There are eight tentative approvals for this compound. Additional details are available on the oxaliplatin profile page.

Summary for NDA: 200979

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

Pharmacology for NDA: 200979

Suppliers and Packaging for NDA: 200979

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXALIPLATIN
oxaliplatin
INJECTABLE;IV (INFUSION) 200979 ANDA Pfizer Laboratories Div Pfizer Inc. 0069-0067 0069-0067-01 10 mL in 1 VIAL (0069-0067-01)
OXALIPLATIN
oxaliplatin
INJECTABLE;IV (INFUSION) 200979 ANDA Pfizer Laboratories Div Pfizer Inc. 0069-1010 0069-1010-01 20 mL in 1 VIAL (0069-1010-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength50MG/VIAL
Approval Date:Aug 8, 2012TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength100MG/VIAL
Approval Date:Aug 8, 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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