APPLICATION
ANDA075772
TYPE
ANDA
ORIGINAL APPROVAL
2004-07-21
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 60MG/2ML · INJECTABLE · INJECTION
KETOROLAC TROMETHAMINEPrescription
KETOROLAC TROMETHAMINE 15MG/ML · INJECTABLE · INJECTION
Approval history
2024-11-21Labeling · Supplement 12 · standardAP
2023-09-21Labeling · Supplement 10 · standardAP
2023-09-21Labeling · Supplement 11 · standardAP
2021-04-28Labeling · Supplement 8 · standardAP
2019-01-28Manufacturing (CMC) · Supplement 5 · unknownAP
2016-05-09Labeling · Supplement 4 · standardAP
2004-07-21OriginalAP
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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