FDA NDA · NDA021746

SURFAXIN

Sponsor: LEES PHARM HK

APPLICATION

NDA021746

TYPE

NDA

ORIGINAL APPROVAL

2012-03-06

LATEST ACTION

2014-04-03

ROUTE

INTRATRACHEAL

DOSAGE FORM

SUSPENSION

MARKETING STATUS

Discontinued

Products

SURFAXINDiscontinued

LUCINACTANT 8.5ML · SUSPENSION · INTRATRACHEAL

2014-04-03Manufacturing (CMC) · Supplement 4 · standardAP

2013-10-03Manufacturing (CMC) · Supplement 3 · standardAP

2013-04-10Manufacturing (CMC) · Supplement 2 · standardAP

2012-12-19Manufacturing (CMC) · Supplement 1 · standardAP

2012-03-06Type 1 - New Molecular Entity · Original · standard — Summary Review ↗AP

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

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.