APPLICATION
NDA019216
TYPE
NDA
ORIGINAL APPROVAL
1986-04-23
LATEST ACTION
2025-02-13
ROUTE
OPHTHALMIC
DOSAGE FORM
SUSPENSION/DROPS
MARKETING STATUS
Prescription
Products
FML FORTE · ReferencePrescription
FLUOROMETHOLONE 0.25% · SUSPENSION/DROPS · OPHTHALMIC
Approval history
2002-09-04Manufacturing (CMC) · Supplement 20 · standardAP
2002-04-12Manufacturing (CMC) · Supplement 19 · standardAP
2001-12-04Manufacturing (CMC) · Supplement 18 · standardAP
2001-09-28Manufacturing (CMC) · Supplement 17 · standardAP
2001-04-12Manufacturing (CMC) · Supplement 16 · standardAP
2000-10-02Manufacturing (CMC) · Supplement 15 · standardAP
1998-09-14Manufacturing (CMC) · Supplement 14 · standardAP
1998-05-08Manufacturing (CMC) · Supplement 12 · standardAP
1997-10-09Manufacturing (CMC) · Supplement 13 · standardAP
1996-12-05Manufacturing (CMC) · Supplement 11 · standardAP
1995-08-03Manufacturing (CMC) · Supplement 9 · standardAP
1994-12-22Manufacturing (CMC) · Supplement 10 · standardAP
1993-09-20Manufacturing (CMC) · Supplement 8 · standardAP
1992-05-21Labeling · Supplement 7AP
1990-05-18Labeling · Supplement 3AP
1990-02-27Manufacturing (CMC) · Supplement 6 · standardAP
1989-10-17Manufacturing (CMC) · Supplement 4 · standardAP
1989-10-13Manufacturing (CMC) · Supplement 5 · standardAP
1986-11-05Manufacturing (CMC) · Supplement 1 · standardAP
1986-08-28Manufacturing (CMC) · Supplement 2 · standardAP
1986-04-23Type 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.
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