APPLICATION
NDA008883
TYPE
NDA
ORIGINAL APPROVAL
1953-07-01
LATEST ACTION
1988-08-08
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
OPHTHAINE · ReferenceDiscontinued
PROPARACAINE HYDROCHLORIDE 0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION/DROPS · OPHTHALMIC
Approval history
1988-08-08Manufacturing (CMC) · Supplement 14 · standardAP
1986-11-05Manufacturing (CMC) · Supplement 13 · standardAP
1985-07-26Manufacturing (CMC) · Supplement 11 · standardAP
1984-05-03Manufacturing (CMC) · Supplement 12 · standardAP
1983-03-22Manufacturing (CMC) · Supplement 10 · standardAP
1982-05-08Labeling · Supplement 9AP
1979-10-04Manufacturing (CMC) · Supplement 8 · standardAP
1978-09-28Labeling · Supplement 5AP
1978-09-28Labeling · Supplement 6AP
1978-08-24Manufacturing (CMC) · Supplement 7 · standardAP
1953-07-01Type 1 - New Molecular Entity · 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.