APPLICATION
ANDA214456
TYPE
ANDA
ORIGINAL APPROVAL
2022-11-02
LATEST ACTION
2024-11-21
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
KETOROLAC TROMETHAMINEPrescription
KETOROLAC TROMETHAMINE 15MG/ML · INJECTABLE · INJECTION
KETOROLAC TROMETHAMINEPrescription
KETOROLAC TROMETHAMINE 30MG/ML · INJECTABLE · INJECTION
Approval history
2024-11-21Labeling · Supplement 5 · standardAP
2023-07-14Labeling · Supplement 3 · standardAP
2023-07-14Labeling · Supplement 1 · standardAP
2022-11-02UNKNOWN · Original · standardAP
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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