APPLICATION
NDA018471
TYPE
NDA
ORIGINAL APPROVAL
1986-05-30
LATEST ACTION
2001-06-06
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
OCUCLEARDiscontinued
OXYMETAZOLINE HYDROCHLORIDE 0.025% · SOLUTION/DROPS · OPHTHALMIC
Approval history
2001-06-06Manufacturing (CMC) · Supplement 16 · standardAP
2001-01-24Manufacturing (CMC) · Supplement 15 · standardAP
1997-07-14Manufacturing (CMC) · Supplement 14 · standardAP
1996-11-13Manufacturing (CMC) · Supplement 13 · standardAP
1990-05-16Manufacturing (CMC) · Supplement 12 · standardAP
1989-08-24Labeling · Supplement 11AP
1989-06-09Manufacturing (CMC) · Supplement 7 · standardAP
1989-04-06Manufacturing (CMC) · Supplement 8 · standardAP
1989-03-30Manufacturing (CMC) · Supplement 6 · standardAP
1988-01-15Manufacturing (CMC) · Supplement 5 · standardAP
1987-08-04Manufacturing (CMC) · Supplement 4 · standardAP
1987-08-03Manufacturing (CMC) · Supplement 2 · standardAP
1987-05-12Manufacturing (CMC) · Supplement 3 · standardAP
1986-08-20Manufacturing (CMC) · Supplement 1 · standardAP
1986-05-30Type 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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