APPLICATION
ANDA077308
TYPE
ANDA
ORIGINAL APPROVAL
2009-11-05
LATEST ACTION
2017-12-27
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
KETOROLAC TROMETHAMINEDiscontinued
KETOROLAC TROMETHAMINE 0.4% · SOLUTION/DROPS · OPHTHALMIC
Approval history
2017-12-27Labeling · Supplement 7 · standardAP
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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