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Generated: May 29, 2017

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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 Qilu Pharm Co Ltd, Aurobindo Pharma Ltd, Sandoz Inc, Akorn Inc, Lupin, Teva Pharms Usa, Acs Dobfar, Hospira Inc, Hikma Farmaceutica, Fresenius Kabi Usa, Samson Medcl, Teva, Bedford, Agila Speclts, Sandoz, Facta Farma, Wockhardt, Cephazone Pharma, B Braun, Baxter Hlthcare, and Sagent Pharms, and is included in thirty-three 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-three 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 NDA: 065168

Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 065168


Suppliers and Packaging for NDA: 065168

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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 sodium
INJECTABLE;INJECTION 065168 ANDA Sandoz Inc 0781-3210 0781-3210-46 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (0781-3210-46) > 100 mL in 1 VIAL, PHARMACY BULK PACKAGE

Summary for product number 001

Approval Date:May 17, 2005TE:APRLD:No

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