APPLICATION
ANDA074955
TYPE
ANDA
ORIGINAL APPROVAL
1997-09-19
LATEST ACTION
2019-10-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
KETOROLAC TROMETHAMINEDiscontinued
KETOROLAC TROMETHAMINE 10MG · TABLET · ORAL
Approval history
2019-10-18Labeling · Supplement 4 · standardAP
2016-05-09Labeling · Supplement 3 · standardAP
1998-07-16Manufacturing (CMC) · Supplement 1AP
1997-09-19OriginalAP
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.