← FDA DRUG APPROVALS

FDA ANDA · ANDA065245

CEFTRIAXONE

Sponsor: FRESENIUS KABI USA

APPLICATION
ANDA065245
TYPE
ANDA
ORIGINAL APPROVAL
2006-02-15
LATEST ACTION
2011-08-04
ROUTE
INTRAMUSCULAR, INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

CEFTRIAXONEDiscontinued
CEFTRIAXONE SODIUM EQ 2GM BASE/VIAL · INJECTABLE · INTRAMUSCULAR, INTRAVENOUS
CEFTRIAXONEDiscontinued
CEFTRIAXONE SODIUM EQ 500MG BASE/VIAL · INJECTABLE · INTRAMUSCULAR, INTRAVENOUS
CEFTRIAXONEDiscontinued
CEFTRIAXONE SODIUM EQ 1GM BASE/VIAL · INJECTABLE · INTRAMUSCULAR, INTRAVENOUS
CEFTRIAXONEDiscontinued
CEFTRIAXONE SODIUM EQ 250MG BASE/VIAL · INJECTABLE · INTRAMUSCULAR, INTRAVENOUS

Approval history

2011-08-04Labeling · Supplement 5AP
2010-06-03Labeling · Supplement 3AP
2009-04-21Labeling · Supplement 2AP
2009-01-16Labeling · Supplement 1AP
2006-02-15OriginalOther Important Information from FDAAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →