APPLICATION
NDA019972
TYPE
NDA
ORIGINAL APPROVAL
1990-05-23
LATEST ACTION
2001-05-22
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
OCUPRESS · ReferenceDiscontinued
CARTEOLOL HYDROCHLORIDE 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION/DROPS · OPHTHALMIC
Approval history
2001-05-22Manufacturing (CMC) · Supplement 18 · standardAP
2001-03-29Manufacturing (CMC) · Supplement 17 · standardAP
2000-12-26Manufacturing (CMC) · Supplement 16 · standardAP
1998-12-18Manufacturing (CMC) · Supplement 15 · standardAP
1997-11-24Manufacturing (CMC) · Supplement 14 · standardAP
1997-02-20Manufacturing (CMC) · Supplement 12 · standardAP
1996-10-22Manufacturing (CMC) · Supplement 13 · standardAP
1996-08-06Manufacturing (CMC) · Supplement 11 · standardAP
1996-08-06Manufacturing (CMC) · Supplement 10 · standardAP
1996-07-31Manufacturing (CMC) · Supplement 8 · standardAP
1996-05-20Manufacturing (CMC) · Supplement 6 · standardAP
1996-05-20Manufacturing (CMC) · Supplement 7 · standardAP
1996-05-20Manufacturing (CMC) · Supplement 5 · standardAP
1996-04-16Manufacturing (CMC) · Supplement 2 · standardAP
1996-04-01Manufacturing (CMC) · Supplement 9 · standardAP
1996-03-18Manufacturing (CMC) · Supplement 4 · standardAP
1996-03-18Manufacturing (CMC) · Supplement 3 · standardAP
1994-06-20Labeling · Supplement 1 · standardAP
1990-05-23Type 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.