APPLICATION
ANDA074754
TYPE
ANDA
ORIGINAL APPROVAL
1997-05-16
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
KETOROLAC TROMETHAMINEPrescription
KETOROLAC TROMETHAMINE 10MG · TABLET · ORAL
Approval history
2024-11-21Labeling · Supplement 27 · standardAP
2022-12-06Labeling · Supplement 22 · standardAP
2021-04-28Labeling · Supplement 20 · standardAP
2016-05-09Labeling · Supplement 18 · standardAP
2015-06-30Labeling · Supplement 17 · standardAP
2012-08-20Labeling · Supplement 14AP
2007-06-19Labeling · Supplement 10AP
2007-02-06Labeling · Supplement 9AP
2001-08-30Manufacturing (CMC) · Supplement 5AP
2000-07-07Manufacturing (CMC) · Supplement 4AP
1998-12-01Manufacturing (CMC) · Supplement 3AP
1998-06-09Manufacturing (CMC) · Supplement 2AP
1998-03-09Manufacturing (CMC) · Supplement 1AP
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.