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Serving leading biopharmaceutical companies globally:

Argus Health
Moodys
QuintilesIMS
McKesson
Cipla
Daiichi Sankyo
Teva
Novartis
Cerilliant
Citi

Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065245

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NDA 065245 describes CEFTRIAXONE, which is a drug marketed by Acs Dobfar, Agila Speclts, Aurobindo Pharma Ltd, Bedford, Facta Farma, Fresenius Kabi Usa, Hospira Inc, Lupin, Samson Medcl, Sandoz, Sandoz Inc, Teva, Wockhardt, Akorn Inc, Cephazone Pharma, Hikma Farmaceutica, Qilu Pharm Co Ltd, Teva Pharms Usa, B Braun, Baxter Hlthcare, and Sagent Pharms, and is included in thirty-four NDAs. It is available from twenty-seven suppliers. Additional details are available on the CEFTRIAXONE profile page.

The generic ingredient in CEFTRIAXONE is ceftriaxone sodium. There are twenty-four drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the ceftriaxone sodium profile page.
Summary for 065245
Tradename:CEFTRIAXONE
Applicant:Fresenius Kabi Usa
Ingredient:ceftriaxone sodium
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065245
Ingredient-typeCephalosporins
Medical Subject Heading (MeSH) Categories for 065245
Suppliers and Packaging for NDA: 065245
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFTRIAXONE ceftriaxone sodium INJECTABLE;INTRAMUSCULAR, INTRAVENOUS 065245 ANDA APP Pharmaceuticals, LLC 63323-344 63323-344-10 25 VIAL in 1 TRAY (63323-344-10) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INTRAMUSCULAR, INTRAVENOUSStrengthEQ 250MG BASE/VIAL
Approval Date:Feb 15, 2006TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INTRAMUSCULAR, INTRAVENOUSStrengthEQ 500MG BASE/VIAL
Approval Date:Feb 15, 2006TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INTRAMUSCULAR, INTRAVENOUSStrengthEQ 1GM BASE/VIAL
Approval Date:Feb 15, 2006TE:RLD:No

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Serving leading biopharmaceutical companies globally:

Queensland Health
Farmers Insurance
Moodys
Citi
US Army
Medtronic
Covington
Fish and Richardson
Argus Health

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