APPLICATION
ANDA076271
TYPE
ANDA
ORIGINAL APPROVAL
2004-10-06
LATEST ACTION
2024-11-21
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription
Products
KETOROLAC TROMETHAMINEDiscontinued
KETOROLAC TROMETHAMINE 15MG/ML · INJECTABLE · INJECTION
KETOROLAC TROMETHAMINEPrescription
KETOROLAC TROMETHAMINE 30MG/ML · INJECTABLE · INJECTION
Approval history
2024-11-21Labeling · Supplement 15 · standardAP
2023-10-11Labeling · Supplement 13 · standardAP
2023-10-11Labeling · Supplement 14 · standardAP
2021-04-28Labeling · Supplement 12 · standardAP
2019-10-28Labeling · Supplement 7 · standardAP
2016-05-09Labeling · Supplement 6 · standardAP
2012-03-15Labeling · Supplement 3AP
2004-10-06OriginalAP
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.
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