APPLICATION
NDA019387
TYPE
NDA
ORIGINAL APPROVAL
1988-12-23
LATEST ACTION
2000-02-18
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
PROFENALDiscontinued
SUPROFEN 1% · SOLUTION/DROPS · OPHTHALMIC
Approval history
2000-02-18Manufacturing (CMC) · Supplement 11 · standardAP
1999-08-17Manufacturing (CMC) · Supplement 10 · standardAP
1999-03-11Manufacturing (CMC) · Supplement 8 · standardAP
1999-02-05Manufacturing (CMC) · Supplement 9 · standardAP
1998-01-15Manufacturing (CMC) · Supplement 6 · standardAP
1998-01-15Manufacturing (CMC) · Supplement 7 · standardAP
1995-11-01Manufacturing (CMC) · Supplement 5 · standardAP
1993-08-13Manufacturing (CMC) · Supplement 3 · standardAP
1993-01-22Manufacturing (CMC) · Supplement 4 · standardAP
1992-08-25Labeling · Supplement 2AP
1992-05-21Labeling · Supplement 1AP
1988-12-23Type 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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