APPLICATION
NDA017468
TYPE
NDA
ORIGINAL APPROVAL
1973-07-10
LATEST ACTION
2003-04-17
ROUTE
OPHTHALMIC
DOSAGE FORM
SUSPENSION/DROPS
MARKETING STATUS
Discontinued
Products
ECONOPREDDiscontinued
PREDNISOLONE ACETATE 0.125% · SUSPENSION/DROPS · OPHTHALMIC
Approval history
1999-08-17Manufacturing (CMC) · Supplement 18 · standardAP
1999-04-07Manufacturing (CMC) · Supplement 17 · standardAP
1998-08-04Manufacturing (CMC) · Supplement 16 · standardAP
1996-03-18Manufacturing (CMC) · Supplement 15 · standardAP
1995-11-01Manufacturing (CMC) · Supplement 14 · standardAP
1995-11-01Manufacturing (CMC) · Supplement 13 · standardAP
1995-06-13Manufacturing (CMC) · Supplement 12 · standardAP
1991-08-22Labeling · Supplement 11AP
1989-03-06Labeling · Supplement 8AP
1988-03-02Manufacturing (CMC) · Supplement 10 · standardAP
1986-03-12Manufacturing (CMC) · Supplement 9 · standardAP
1982-05-25Manufacturing (CMC) · Supplement 7 · standardAP
1979-05-24Manufacturing (CMC) · Supplement 5 · standardAP
1977-05-20Manufacturing (CMC) · Supplement 2 · standardAP
1977-04-06Manufacturing (CMC) · Supplement 3 · standardAP
1973-07-10Type 5 - New Formulation or New Manufacturer · 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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