APPLICATION
NDA019079
TYPE
NDA
ORIGINAL APPROVAL
1986-02-11
LATEST ACTION
2025-09-23
ROUTE
OPHTHALMIC
DOSAGE FORM
SUSPENSION/DROPS
MARKETING STATUS
Prescription
Products
FLAREX · ReferencePrescription
FLUOROMETHOLONE ACETATE 0.1% · SUSPENSION/DROPS · OPHTHALMIC
Approval history
2002-12-11Manufacturing (CMC) · Supplement 23 · standardAP
2002-12-04Manufacturing (CMC) · Supplement 22 · standardAP
2002-06-10Manufacturing (CMC) · Supplement 21 · standardAP
2001-03-16Manufacturing (CMC) · Supplement 20 · standardAP
2000-02-18Manufacturing (CMC) · Supplement 18 · standardAP
1999-11-05Manufacturing (CMC) · Supplement 17 · standardAP
1999-08-17Manufacturing (CMC) · Supplement 16 · standardAP
1999-03-11Manufacturing (CMC) · Supplement 14 · standardAP
1999-02-05Manufacturing (CMC) · Supplement 15 · standardAP
1999-02-04Manufacturing (CMC) · Supplement 13 · standardAP
1998-08-04Manufacturing (CMC) · Supplement 12 · standardAP
1997-07-30Manufacturing (CMC) · Supplement 11 · standardAP
1997-04-21Manufacturing (CMC) · Supplement 10 · standardAP
1996-09-26Labeling · Supplement 9 · standardAP
1996-07-19Manufacturing (CMC) · Supplement 8 · standardAP
1996-03-18Manufacturing (CMC) · Supplement 7 · standardAP
1995-11-01Manufacturing (CMC) · Supplement 6 · standardAP
1995-11-01Manufacturing (CMC) · Supplement 5 · standardAP
1995-06-13Manufacturing (CMC) · Supplement 4 · standardAP
1987-03-04Manufacturing (CMC) · Supplement 3 · standardAP
1986-12-09Labeling · Supplement 2AP
1986-03-24Manufacturing (CMC) · Supplement 1 · standardAP
1986-02-11Type 2 - New Active Ingredient · 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.
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