BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Moodys
Baxter
Deloitte
Argus Health
US Department of Justice
Chubb
Queensland Health
Harvard Business School
Fuji
Covington

Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065230

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NDA 065230 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 065230
Tradename:CEFTRIAXONE
Applicant:Hospira Inc
Ingredient:ceftriaxone sodium
Patents:0
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 065230
Ingredient-typeCephalosporins
Medical Subject Heading (MeSH) Categories for 065230
Suppliers and Packaging for NDA: 065230
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFTRIAXONE ceftriaxone sodium INJECTABLE;INTRAMUSCULAR, INTRAVENOUS 065230 ANDA Rebel Distributors Corp 21695-202 21695-202-10 10 VIAL in 1 BOX (21695-202-10) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL
CEFTRIAXONE ceftriaxone sodium INJECTABLE;INTRAMUSCULAR, INTRAVENOUS 065230 ANDA Rebel Distributors Corp 21695-352 21695-352-01 1 INJECTION, POWDER, FOR SOLUTION in 1 BOX (21695-352-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAMUSCULAR, INTRAVENOUSStrengthEQ 250MG BASE/VIAL
Approval Date:Aug 2, 2005TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAMUSCULAR, INTRAVENOUSStrengthEQ 500MG BASE/VIAL
Approval Date:Aug 2, 2005TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAMUSCULAR, INTRAVENOUSStrengthEQ 1GM BASE/VIAL
Approval Date:Aug 2, 2005TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

Julphar
US Army
Merck
Baxter
Federal Trade Commission
Cantor Fitzgerald
Cipla
Chubb
Mallinckrodt

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