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Generated: January 22, 2019

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Details for New Drug Application (NDA): 065168

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NDA 065168 describes CEFTRIAXONE, which is a drug marketed by Acs Dobfar, Agila Speclts, Aurobindo Pharma Ltd, Bedford, Facta Farma, Fresenius Kabi Usa, Hospira Inc, Lupin, Qilu Pharm Co Ltd, Samson Medcl, Sandoz, Sandoz Inc, Teva, Wockhardt, Akorn Inc, Astral, Cephazone Pharma, Hikma Farmaceutica, Teva Pharms Usa, B Braun, and Baxter Hlthcare, and is included in thirty-six 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 065168
Tradename:CEFTRIAXONE
Applicant:Sandoz
Ingredient:ceftriaxone sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 065168
Medical Subject Heading (MeSH) Categories for 065168
Suppliers and Packaging for NDA: 065168
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CEFTRIAXONE ceftriaxone sodium INJECTABLE;INJECTION 065168 ANDA Hospira, Inc 0409-7334 0409-7334-10 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0409-7334-10) > 100 mL in 1 VIAL, PHARMACY BULK PACKAGE
CEFTRIAXONE ceftriaxone sodium INJECTABLE;INJECTION 065168 ANDA Hospira, Inc 0409-7334 0409-7334-20 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0409-7334-20) > 100 mL in 1 VIAL, PHARMACY BULK PACKAGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 10GM BASE/VIAL
Approval Date:May 17, 2005TE:APRLD:No

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