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Serving hundreds of leading biopharmaceutical companies globally:

Generated: April 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065329

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NDA 065329 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-five 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-six suppliers are listed for this compound. Additional details are available on the ceftriaxone sodium profile page.

Summary for 065329

Tradename:	CEFTRIAXONE
Applicant:	Acs Dobfar
Ingredient:	ceftriaxone sodium
Patents:	0
Therapeutic Class:	Antibacterials
Formulation / Manufacturing:	see details

Pharmacology for NDA: 065329

Ingredient-type	Cephalosporins

Medical Subject Heading (MeSH) Categories for 065329

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 065329

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CEFTRIAXONE	ceftriaxone sodium	INJECTABLE;INJECTION	065329	ANDA	Sagent Pharmaceuticals	25021-105	N	25021-105-66
CEFTRIAXONE	ceftriaxone sodium	INJECTABLE;INJECTION	065329	ANDA	Sagent Pharmaceuticals	25021-105	N	25021-105-10

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 500MG BASE/VIAL
Approval Date:	Jul 24, 2008	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 1GM BASE/VIAL
Approval Date:	Jul 24, 2008	TE:	AP	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 2GM BASE/VIAL
Approval Date:	Jul 24, 2008	TE:	AP	RLD:	No

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