APPLICATION
ANDA077942
TYPE
ANDA
ORIGINAL APPROVAL
2007-03-27
LATEST ACTION
2024-11-21
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
KETOROLAC TROMETHAMINEPrescription
KETOROLAC TROMETHAMINE 15MG/ML · INJECTABLE · INJECTION
KETOROLAC TROMETHAMINEPrescription
KETOROLAC TROMETHAMINE 30MG/ML · INJECTABLE · INJECTION
Approval history
2024-11-21Labeling · Supplement 8 · standardAP
2024-06-18Labeling · Supplement 6 · standardAP
2024-06-18Labeling · Supplement 7 · standardAP
2021-04-29Labeling · Supplement 5 · standardAP
2016-05-09Labeling · Supplement 4 · standardAP
2007-03-27OriginalAP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.