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Generated: October 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204616

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NDA 204616 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 nineteen 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-two suppliers are listed for this compound. Additional details are available on the oxaliplatin profile page.

Summary for NDA: 204616

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

Pharmacology for NDA: 204616

Suppliers and Packaging for NDA: 204616

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXALIPLATIN
oxaliplatin
INJECTABLE;IV (INFUSION) 204616 ANDA Breckenridge Pharmaceutical, Inc. 51991-218 51991-218-98 1 VIAL, SINGLE-DOSE in 1 CARTON (51991-218-98) > 10 mL in 1 VIAL, SINGLE-DOSE
OXALIPLATIN
oxaliplatin
INJECTABLE;IV (INFUSION) 204616 ANDA Breckenridge Pharmaceutical, Inc. 51991-219 51991-219-98 1 VIAL, SINGLE-DOSE in 1 CARTON (51991-219-98) > 20 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength50MG/VIAL
Approval Date:May 11, 2016TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;IV (INFUSION)Strength100MG/VIAL
Approval Date:May 11, 2016TE:APRLD:No


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