APPLICATION
ANDA204216
TYPE
ANDA
ORIGINAL APPROVAL
2016-11-01
LATEST ACTION
2024-11-21
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
KETOROLAC TROMETHAMINEPrescription
KETOROLAC TROMETHAMINE 30MG/ML · INJECTABLE · INJECTION
KETOROLAC TROMETHAMINEPrescription
KETOROLAC TROMETHAMINE 15MG/ML · INJECTABLE · INJECTION
Approval history
2024-11-21Labeling · Supplement 15 · standardAP
2023-07-10Labeling · Supplement 13 · standardAP
2023-07-10Labeling · Supplement 11 · standardAP
2021-04-28Labeling · Supplement 10 · standardAP
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.