APPLICATION
ANDA075222
TYPE
ANDA
ORIGINAL APPROVAL
1999-04-26
LATEST ACTION
2024-11-21
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
KETOROLAC TROMETHAMINEDiscontinued
KETOROLAC TROMETHAMINE 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
KETOROLAC TROMETHAMINEDiscontinued
KETOROLAC TROMETHAMINE 30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2024-11-21Labeling · Supplement 23 · standardAP
2024-07-11Labeling · Supplement 22 · standardAP
2022-11-09Labeling · Supplement 21 · standardAP
2021-04-28Labeling · Supplement 20 · standardAP
2011-03-08Labeling · Supplement 14AP
2008-08-05Labeling · Supplement 13AP
2007-07-21Labeling · Supplement 12AP
2007-02-07Labeling · Supplement 11AP
2002-12-20Manufacturing (CMC) · Supplement 3AP
2002-09-17Manufacturing (CMC) · Supplement 2AP
2001-04-03Manufacturing (CMC) · Supplement 1AP
1999-04-26OriginalAP
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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