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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 065328

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NDA 065328 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, Deva Holding As, Epic Pharma Llc, Hikma Farmaceutica, 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 are twenty-six drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the ceftriaxone sodium profile page.

Summary for 065328

Tradename:	CEFTRIAXONE
Applicant:	Acs Dobfar
Ingredient:	ceftriaxone sodium
Patents:	0

Pharmacology for NDA: 065328

Medical Subject Heading (MeSH) Categories for 065328

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 065328

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CEFTRIAXONE	ceftriaxone sodium	INJECTABLE;INJECTION	065328	ANDA	WG Critical Care, LLC	44567-703	44567-703-01	1 VIAL in 1 CARTON (44567-703-01) / 100 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 10GM BASE/VIAL
Approval Date:	Jul 24, 2008	TE:	AP	RLD:	No

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