APPLICATION
NDA010210
TYPE
NDA
ORIGINAL APPROVAL
1965-06-23
LATEST ACTION
1999-10-01
ROUTE
OPHTHALMIC
DOSAGE FORM
SUSPENSION/DROPS, OINTMENT
MARKETING STATUS
Discontinued
Products
METIMYDDiscontinued
PREDNISOLONE ACETATE 0.5%, SULFACETAMIDE SODIUM 10% · SUSPENSION/DROPS · OPHTHALMIC
METIMYDDiscontinued
PREDNISOLONE ACETATE 0.5%, SULFACETAMIDE SODIUM 10% · OINTMENT · OPHTHALMIC
Approval history
1999-10-01Manufacturing (CMC) · Supplement 23 · standardAP
1997-08-21Manufacturing (CMC) · Supplement 22 · standardAP
1997-06-26Manufacturing (CMC) · Supplement 21 · standardAP
1996-11-13Manufacturing (CMC) · Supplement 20 · standardAP
1994-12-30Labeling · Supplement 19 · standardAP
1989-04-06Manufacturing (CMC) · Supplement 18 · standardAP
1989-01-03Manufacturing (CMC) · Supplement 17 · standardAP
1988-03-23Labeling · Supplement 7 · standardAP
1988-03-23Labeling · Supplement 8 · standardAP
1988-03-23Labeling · Supplement 6 · standardAP
1987-05-12Manufacturing (CMC) · Supplement 16 · standardAP
1987-03-16Manufacturing (CMC) · Supplement 15 · standardAP
1986-05-20Manufacturing (CMC) · Supplement 14 · standardAP
1986-04-28Manufacturing (CMC) · Supplement 13 · standardAP
1986-04-28Manufacturing (CMC) · Supplement 12 · standardAP
1986-03-11Manufacturing (CMC) · Supplement 11 · standardAP
1984-09-09Labeling · Supplement 9 · standardAP
1984-09-09Labeling · Supplement 10 · standardAP
1965-06-23Type 4 - New Combination · 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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