APPLICATION
NDA017011
TYPE
NDA
ORIGINAL APPROVAL
1973-05-30
LATEST ACTION
2018-06-06
ROUTE
OPHTHALMIC
DOSAGE FORM
SUSPENSION/DROPS
MARKETING STATUS
Prescription
Products
PRED FORTE · ReferencePrescription
PREDNISOLONE ACETATE 1% · SUSPENSION/DROPS · OPHTHALMIC
Approval history
2002-04-12Manufacturing (CMC) · Supplement 41 · standardAP
2001-12-04Manufacturing (CMC) · Supplement 39 · standardAP
2001-09-28Manufacturing (CMC) · Supplement 38 · standardAP
2001-07-24Manufacturing (CMC) · Supplement 37 · standardAP
2001-04-12Manufacturing (CMC) · Supplement 36 · standardAP
2000-10-02Manufacturing (CMC) · Supplement 35 · standardAP
1998-05-19Manufacturing (CMC) · Supplement 34 · standardAP
1997-09-30Manufacturing (CMC) · Supplement 33 · standardAP
1996-12-05Manufacturing (CMC) · Supplement 32 · standardAP
1995-08-03Manufacturing (CMC) · Supplement 30 · standardAP
1995-05-10Manufacturing (CMC) · Supplement 31 · standardAP
1989-10-30Manufacturing (CMC) · Supplement 29 · standardAP
1989-10-12Manufacturing (CMC) · Supplement 28 · standardAP
1988-09-09Manufacturing (CMC) · Supplement 27 · standardAP
1988-02-17Labeling · Supplement 26AP
1987-11-03Manufacturing (CMC) · Supplement 25 · standardAP
1987-04-30Manufacturing (CMC) · Supplement 24 · standardAP
1986-06-13Manufacturing (CMC) · Supplement 23 · standardAP
1986-06-13Manufacturing (CMC) · Supplement 22 · standardAP
1986-04-15Labeling · Supplement 21AP
1983-07-11Manufacturing (CMC) · Supplement 16 · standardAP
1982-09-03Manufacturing (CMC) · Supplement 14 · standardAP
1982-09-02Manufacturing (CMC) · Supplement 13 · standardAP
1982-08-13Manufacturing (CMC) · Supplement 17 · standardAP
1980-01-22Manufacturing (CMC) · Supplement 12 · standardAP
1979-11-19Manufacturing (CMC) · Supplement 11 · standardAP
1975-08-05Labeling · Supplement 3AP
1974-11-26Manufacturing (CMC) · Supplement 1 · standardAP
1973-05-30Type 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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