APPLICATION
NDA019700
TYPE
NDA
ORIGINAL APPROVAL
1992-11-09
LATEST ACTION
2025-09-18
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription
Products
ACULAR · ReferencePrescription
KETOROLAC TROMETHAMINE 0.5% · SOLUTION/DROPS · OPHTHALMIC
Approval history
2002-04-15Manufacturing (CMC) · Supplement 21 · standardAP
2002-04-12Manufacturing (CMC) · Supplement 22 · standardAP
2001-12-04Manufacturing (CMC) · Supplement 20 · standardAP
2001-04-27Labeling · Supplement 14 · standardAP
2001-04-12Manufacturing (CMC) · Supplement 17 · standardAP
2000-10-02Manufacturing (CMC) · Supplement 16 · standardAP
1998-05-19Manufacturing (CMC) · Supplement 12 · standardAP
1998-02-04Manufacturing (CMC) · Supplement 13 · standardAP
1997-07-21Manufacturing (CMC) · Supplement 11 · standardAP
1997-04-30Manufacturing (CMC) · Supplement 9 · standardAP
1996-12-31Efficacy · Supplement 7 · standardAP
1996-09-18Labeling · Supplement 4 · standardAP
1996-09-18Manufacturing (CMC) · Supplement 5 · standardAP
1996-09-18Efficacy · Supplement 3 · standardAP
1996-07-11Manufacturing (CMC) · Supplement 6 · standardAP
1996-03-29Manufacturing (CMC) · Supplement 2 · standardAP
1994-04-14Manufacturing (CMC) · Supplement 1 · standardAP
1992-11-09Type 3 - New Dosage Form · Original · standardAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.