APPLICATION
NDA016851
TYPE
NDA
ORIGINAL APPROVAL
1972-01-12
LATEST ACTION
2013-02-12
ROUTE
OPHTHALMIC
DOSAGE FORM
SUSPENSION/DROPS
MARKETING STATUS
Prescription
Products
FML · ReferencePrescription
FLUOROMETHOLONE 0.1% · SUSPENSION/DROPS · OPHTHALMIC
Approval history
2003-03-19Labeling · Supplement 59 · standardAP
2002-07-18Manufacturing (CMC) · Supplement 57 · standardAP
2002-04-12Manufacturing (CMC) · Supplement 56 · standardAP
2001-12-04Manufacturing (CMC) · Supplement 55 · standardAP
2001-07-24Manufacturing (CMC) · Supplement 54 · standardAP
2001-04-12Manufacturing (CMC) · Supplement 53 · standardAP
2000-10-02Manufacturing (CMC) · Supplement 52 · standardAP
1998-06-30Manufacturing (CMC) · Supplement 50 · standardAP
1998-05-01Manufacturing (CMC) · Supplement 49 · standardAP
1996-12-18Manufacturing (CMC) · Supplement 48 · standardAP
1996-12-05Manufacturing (CMC) · Supplement 47 · standardAP
1995-08-03Manufacturing (CMC) · Supplement 45 · standardAP
1994-12-22Manufacturing (CMC) · Supplement 46 · standardAP
1993-09-20Manufacturing (CMC) · Supplement 44 · standardAP
1993-06-08Manufacturing (CMC) · Supplement 43 · standardAP
1992-05-20Labeling · Supplement 38AP
1992-05-20Labeling · Supplement 42AP
1989-10-12Manufacturing (CMC) · Supplement 40 · standardAP
1989-04-27Manufacturing (CMC) · Supplement 41 · standardAP
1989-02-01Manufacturing (CMC) · Supplement 39 · standardAP
1986-07-18Manufacturing (CMC) · Supplement 37 · standardAP
1984-05-31Manufacturing (CMC) · Supplement 35 · standardAP
1983-03-14Manufacturing (CMC) · Supplement 33 · standardAP
1982-08-13Manufacturing (CMC) · Supplement 32 · standardAP
1982-07-28Manufacturing (CMC) · Supplement 30 · standardAP
1982-07-28Manufacturing (CMC) · Supplement 29 · standardAP
1980-01-30Manufacturing (CMC) · Supplement 28 · standardAP
1979-09-27Manufacturing (CMC) · Supplement 27 · standardAP
1979-08-09Manufacturing (CMC) · Supplement 26 · standardAP
1978-09-20Manufacturing (CMC) · Supplement 16 · standardAP
1978-09-20Labeling · Supplement 14AP
1978-09-12Manufacturing (CMC) · Supplement 24 · standardAP
1978-08-14Labeling · Supplement 19AP
1978-08-14Labeling · Supplement 25AP
1978-08-14Labeling · Supplement 17AP
1978-08-14Labeling · Supplement 23AP
1978-08-14Labeling · Supplement 21AP
1978-08-14Labeling · Supplement 22AP
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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