APPLICATION
NDA009048
TYPE
NDA
ORIGINAL APPROVAL
1954-12-03
LATEST ACTION
2015-07-30
ROUTE
ORAL, TOPICAL
DOSAGE FORM
CAPSULE, LOTION
MARKETING STATUS
Discontinued
Products
8-MOP · ReferenceDiscontinued
METHOXSALEN 10MG · CAPSULE · ORAL
OXSORALEN · ReferenceDiscontinued
METHOXSALEN 1% · LOTION · TOPICAL
Approval history
2015-07-30Manufacturing (CMC) · Supplement 48 · priorityAP
2015-07-28Manufacturing (CMC) · Supplement 47 · priorityAP
2013-09-20Labeling · Supplement 46 · unknownAP
2013-03-22Manufacturing (CMC) · Supplement 45 · priorityAP
2001-10-31Manufacturing (CMC) · Supplement 40 · priorityAP
2000-04-05Manufacturing (CMC) · Supplement 38 · priorityAP
1998-04-07Manufacturing (CMC) · Supplement 36 · priorityAP
1998-03-16Manufacturing (CMC) · Supplement 35 · priorityAP
1997-09-23Manufacturing (CMC) · Supplement 34 · priorityAP
1997-09-23Manufacturing (CMC) · Supplement 33 · priorityAP
1996-01-25Manufacturing (CMC) · Supplement 31 · priorityAP
1988-03-23Efficacy · Supplement 30AP
1984-04-16Labeling · Supplement 25AP
1983-04-21Labeling · Supplement 22AP
1982-05-07Labeling · Supplement 20AP
1982-05-07Labeling · Supplement 21AP
1975-04-04Labeling · Supplement 6AP
1974-11-13Supplement · Supplement 5 · priorityAP
1954-12-03Type 1 - New Molecular Entity · Original · priorityAP
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.