Last Updated: November 8, 2026

Details for New Drug Application (NDA): 065305

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NDA 065305 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 065305

Tradename:	CEFTRIAXONE
Applicant:	Epic Pharma Llc
Ingredient:	ceftriaxone sodium
Patents:	0

Medical Subject Heading (MeSH) Categories for 065305

Anti-Bacterial Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS			Strength	EQ 250MG BASE/VIAL
Approval Date:	Jan 11, 2008	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS			Strength	EQ 500MG BASE/VIAL
Approval Date:	Jan 11, 2008	TE:	AP	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS			Strength	EQ 1GM BASE/VIAL
Approval Date:	Jan 11, 2008	TE:	AP	RLD:	No

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