APPLICATION
ANDA074761
TYPE
ANDA
ORIGINAL APPROVAL
1997-05-16
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
KETOROLAC TROMETHAMINEPrescription
KETOROLAC TROMETHAMINE 10MG · TABLET · ORAL
Approval history
2024-11-21Labeling · Supplement 22 · standardAP
2021-04-28Labeling · Supplement 15 · standardAP
2016-05-09Labeling · Supplement 12 · standardAP
2015-06-29Labeling · Supplement 9 · standardAP
2012-08-20Labeling · Supplement 8AP
2000-06-12Manufacturing (CMC) · Supplement 2AP
1998-01-29Manufacturing (CMC) · Supplement 1AP
1997-05-16OriginalAP
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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