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Generated: November 15, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065169

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NDA 065169 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, Sagent Pharms, Teva Pharms Usa, B Braun, and Baxter Hlthcare, and is included in thirty-five NDAs. It is available from twenty-five suppliers. Additional details are available on the CEFTRIAXONE profile page.

The generic ingredient in CEFTRIAXONE is ceftriaxone sodium. There are twenty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the ceftriaxone sodium profile page.
Summary for 065169
Tradename:CEFTRIAXONE
Applicant:Sandoz
Ingredient:ceftriaxone sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 065169
Ingredient-typeCephalosporins
Medical Subject Heading (MeSH) Categories for 065169
Suppliers and Packaging for NDA: 065169
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFTRIAXONE ceftriaxone sodium INJECTABLE;INTRAMUSCULAR, INTRAVENOUS 065169 ANDA Hospira, Inc 0409-7332 0409-7332-20 10 VIAL, SINGLE-USE in 1 CARTON (0409-7332-20) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE
CEFTRIAXONE ceftriaxone sodium INJECTABLE;INTRAMUSCULAR, INTRAVENOUS 065169 ANDA Hospira, Inc 0409-7332 0409-7332-01 10 VIAL, SINGLE-USE in 1 CARTON (0409-7332-01) > 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, SINGLE-USE (0409-7332-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAMUSCULAR, INTRAVENOUSStrengthEQ 250MG BASE/VIAL
Approval Date:May 9, 2005TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAMUSCULAR, INTRAVENOUSStrengthEQ 500MG BASE/VIAL
Approval Date:May 9, 2005TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAMUSCULAR, INTRAVENOUSStrengthEQ 1GM BASE/VIAL
Approval Date:May 9, 2005TE:APRLD:No

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