APPLICATION
ANDA212939
TYPE
ANDA
ORIGINAL APPROVAL
2020-10-20
LATEST ACTION
2024-11-21
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
KETOROLAC TROMETHAMINEDiscontinued
KETOROLAC TROMETHAMINE 30MG/ML · INJECTABLE · INJECTION
KETOROLAC TROMETHAMINEDiscontinued
KETOROLAC TROMETHAMINE 15MG/ML · INJECTABLE · INJECTION
Approval history
2024-11-21Labeling · Supplement 4 · standardAP
2023-07-03Labeling · Supplement 1 · standardAP
2023-07-03Labeling · Supplement 2 · standardAP
2020-10-20UNKNOWN · Original · 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.