APPLICATION
ANDA075784
TYPE
ANDA
ORIGINAL APPROVAL
2002-01-11
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 28 · standardAP
2024-08-26Labeling · Supplement 24 · standardAP
2024-08-26Labeling · Supplement 25 · standardAP
2021-04-28Labeling · Supplement 20 · standardAP
2016-05-11Labeling · Supplement 14 · standardAP
2016-05-09Labeling · Supplement 13 · standardAP
2002-04-11Labeling · Supplement 1AP
2002-01-11OriginalAP
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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