APPLICATION
ANDA075284
TYPE
ANDA
ORIGINAL APPROVAL
1999-06-23
LATEST ACTION
2016-05-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
KETOROLAC TROMETHAMINEDiscontinued
KETOROLAC TROMETHAMINE 10MG · TABLET · ORAL
Approval history
2016-05-09Labeling · Supplement 11 · standardAP
2007-02-06Labeling · Supplement 6AP
2005-04-12Labeling · Supplement 5AP
2000-07-07Manufacturing (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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