APPLICATION
ANDA074801
TYPE
ANDA
ORIGINAL APPROVAL
1997-06-05
LATEST ACTION
1999-09-23
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
KETOROLAC TROMETHAMINEDiscontinued
KETOROLAC TROMETHAMINE 15MG/ML · INJECTABLE · INJECTION
KETOROLAC TROMETHAMINEDiscontinued
KETOROLAC TROMETHAMINE 30MG/ML · INJECTABLE · INJECTION
Approval history
1999-09-23Manufacturing (CMC) · Supplement 4AP
1997-12-08Labeling · Supplement 3AP
1997-08-11Labeling · Supplement 2AP
1997-06-12Labeling · Supplement 1AP
1997-06-05OriginalAP
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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