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, Apotex, Aurobindo Pharma Ltd, Bedford, Facta Farma, Fresenius Kabi Usa, Hospira Inc, Lupin, Qilu Antibiotics, Samson Medcl, Sandoz, Sandoz Inc, Teva, Astral, Cephazone Pharma, Epic Pharma Llc, Hikma Farmaceutica, Regcon Holdings, Teva Pharms Usa, Wockhardt Bio Ag, B Braun, Baxter Hlthcare, Anda Repository, and Hikma, and is included in thirty-seven NDAs. It is available from fifteen suppliers. Additional details are available on the CEFTRIAXONE profile page.

The generic ingredient in CEFTRIAXONE is ceftriaxone sodium. There is one drug master file entry for this compound. Seventeen 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

Pharmacology for NDA: 065168

Medical Subject Heading (MeSH) Categories for 065168

Anti-Bacterial Agents

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:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 10GM BASE/VIAL
Approval Date:	May 17, 2005	TE:	AP	RLD:	No

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