APPLICATION
ANDA074447
TYPE
ANDA
ORIGINAL APPROVAL
1995-01-04
LATEST ACTION
2013-01-28
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription
Products
FLURBIPROFEN SODIUMPrescription
FLURBIPROFEN SODIUM 0.03% · SOLUTION/DROPS · OPHTHALMIC
Approval history
2013-01-28Labeling · Supplement 23 · standardAP
2002-12-09Labeling · Supplement 13AP
2001-11-27Manufacturing (CMC) · Supplement 12AP
2001-04-30Manufacturing (CMC) · Supplement 11AP
2001-03-07Manufacturing (CMC) · Supplement 10AP
2000-06-27Manufacturing (CMC) · Supplement 9AP
2000-05-18Manufacturing (CMC) · Supplement 7AP
2000-04-28Manufacturing (CMC) · Supplement 8AP
1999-06-07Manufacturing (CMC) · Supplement 6AP
1998-11-19Manufacturing (CMC) · Supplement 4AP
1998-10-22Manufacturing (CMC) · Supplement 2AP
1998-08-24Manufacturing (CMC) · Supplement 5AP
1998-05-28Manufacturing (CMC) · Supplement 3AP
1997-04-08Manufacturing (CMC) · Supplement 1AP
1995-01-04OriginalAP
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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