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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 090057

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NDA 090057 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 Antibiotics, Samson Medcl, Sandoz, Sandoz Inc, Teva, Wockhardt Bio Ag, Astral, Cephazone Pharma, Deva Holding As, Epic Pharma Llc, Hikma Farmaceutica, Teva Pharms Usa, 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. Eighteen suppliers are listed for this compound. Additional details are available on the ceftriaxone sodium profile page.

Summary for 090057

Tradename:	CEFTRIAXONE
Applicant:	Samson Medcl
Ingredient:	ceftriaxone sodium
Patents:	0

Pharmacology for NDA: 090057

Medical Subject Heading (MeSH) Categories for 090057

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 090057

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CEFTRIAXONE	ceftriaxone sodium	INJECTABLE;INJECTION	090057	ANDA	Samson Medical Technologies, LLC	66288-6100	66288-6100-1	1 INJECTION, POWDER, FOR SOLUTION in 1 BAG (66288-6100-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 100GM BASE/VIAL
Approval Date:	Apr 25, 2014	TE:		RLD:	No

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