APPLICATION
ANDA074802
TYPE
ANDA
ORIGINAL APPROVAL
1997-06-05
LATEST ACTION
2024-11-21
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
KETOROLAC TROMETHAMINEPrescription
KETOROLAC TROMETHAMINE 15MG/ML · INJECTABLE · INJECTION
KETOROLAC TROMETHAMINEPrescription
KETOROLAC TROMETHAMINE 30MG/ML · INJECTABLE · INJECTION
Approval history
2024-11-21Labeling · Supplement 59 · standardAP
2022-11-15Labeling · Supplement 52 · standardAP
2021-04-28Labeling · Supplement 48 · standardAP
2016-05-09Labeling · Supplement 40 · standardAP
2013-05-29Labeling · Supplement 37 · standardAP
2003-03-14Labeling · Supplement 22AP
2002-12-16Manufacturing (CMC) · Supplement 18AP
2002-10-25Manufacturing (CMC) · Supplement 20AP
2002-07-29Manufacturing (CMC) · Supplement 19AP
2002-02-04Manufacturing (CMC) · Supplement 16AP
2001-09-17Manufacturing (CMC) · Supplement 17AP
2001-03-22Manufacturing (CMC) · Supplement 13AP
2001-03-22Manufacturing (CMC) · Supplement 12AP
2001-03-06Manufacturing (CMC) · Supplement 14AP
2001-02-14Manufacturing (CMC) · Supplement 15AP
2000-09-25Manufacturing (CMC) · Supplement 11AP
2000-01-07Labeling · Supplement 4AP
2000-01-07Manufacturing (CMC) · Supplement 3AP
1999-12-10Manufacturing (CMC) · Supplement 8AP
1999-12-10Manufacturing (CMC) · Supplement 6AP
1999-12-10Labeling · Supplement 9AP
1999-12-10Manufacturing (CMC) · Supplement 7AP
1999-12-10Manufacturing (CMC) · Supplement 5AP
1999-09-23Manufacturing (CMC) · Supplement 10AP
1997-12-08Labeling · 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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