APPLICATION
ANDA077943
TYPE
ANDA
ORIGINAL APPROVAL
2007-03-27
LATEST ACTION
2024-11-21
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
KETOROLAC TROMETHAMINEDiscontinued
KETOROLAC TROMETHAMINE 30MG/ML · INJECTABLE · INJECTION
Approval history
2024-11-21Labeling · Supplement 6 · standardAP
2024-06-18Labeling · Supplement 4 · standardAP
2024-06-18Labeling · Supplement 5 · standardAP
2021-04-29Labeling · Supplement 3 · standardAP
2016-05-09Labeling · Supplement 2 · standardAP
2007-03-27OriginalAP
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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