APPLICATION
ANDA075299
TYPE
ANDA
ORIGINAL APPROVAL
1999-11-03
LATEST ACTION
2024-11-21
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
2024-11-21Labeling · Supplement 7 · standardAP
2023-09-21Labeling · Supplement 5 · standardAP
2023-09-21Labeling · Supplement 6 · standardAP
2021-04-28Labeling · Supplement 4 · standardAP
2016-05-09Labeling · Supplement 3 · standardAP
2000-09-12Manufacturing (CMC) · Supplement 1AP
2000-09-12Manufacturing (CMC) · Supplement 2AP
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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