APPLICATION
ANDA076109
TYPE
ANDA
ORIGINAL APPROVAL
2009-11-05
LATEST ACTION
2026-01-22
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription
Products
KETOROLAC TROMETHAMINEPrescription
KETOROLAC TROMETHAMINE 0.5% · SOLUTION/DROPS · OPHTHALMIC
Approval history
2026-01-22Labeling · Supplement 19 · standardAP
2018-09-05Manufacturing (CMC) · Supplement 12 · unknownAP
2015-12-11Labeling · Supplement 5 · standardAP
2013-03-28Manufacturing (CMC) · Supplement 1AP
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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