← FDA DRUG APPROVALS

FDA ANDA · ANDA091068

CEFTRIAXONE

Sponsor: AGILA SPECLTS

APPLICATION
ANDA091068
TYPE
ANDA
ORIGINAL APPROVAL
2013-01-07
LATEST ACTION
2014-05-27
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

CEFTRIAXONEDiscontinued
CEFTRIAXONE SODIUM EQ 10GM BASE/VIAL · INJECTABLE · INJECTION

Approval history

2014-05-27Labeling · Supplement 1 · standardAP
2013-01-07OriginalAP
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 →