← FDA DRUG APPROVALS

FDA ANDA · ANDA065230

CEFTRIAXONE

Sponsor: HOSPIRA INC

APPLICATION
ANDA065230
TYPE
ANDA
ORIGINAL APPROVAL
2005-08-02
LATEST ACTION
2011-04-20
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

2011-04-20Labeling · Supplement 14AP
2010-08-31Labeling · Supplement 13AP
2009-08-27Labeling · Supplement 11AP
2009-08-27Labeling · Supplement 12AP
2008-11-14Labeling · Supplement 7AP
2008-11-14Labeling · Supplement 10AP
2005-08-02Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA 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 →