APPLICATION
ANDA070185
TYPE
ANDA
ORIGINAL APPROVAL
1986-02-27
LATEST ACTION
2001-04-19
ROUTE
OPHTHALMIC
DOSAGE FORM
SUSPENSION/DROPS
MARKETING STATUS
Discontinued
Products
FLUOR-OPDiscontinued
FLUOROMETHOLONE 0.1% · SUSPENSION/DROPS · OPHTHALMIC
Approval history
2001-04-19Manufacturing (CMC) · Supplement 8AP
1994-10-07Manufacturing (CMC) · Supplement 5AP
1994-06-10Manufacturing (CMC) · Supplement 6AP
1994-03-07Labeling · Supplement 4AP
1992-10-20Labeling · Supplement 3AP
1988-06-20Labeling · Supplement 2AP
1986-06-10Manufacturing (CMC) · Supplement 1AP
1986-02-27OriginalAP
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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