APPLICATION
NDA018148
TYPE
NDA
ORIGINAL APPROVAL
1981-09-24
LATEST ACTION
2007-12-07
ROUTE
NASAL
DOSAGE FORM
SPRAY, METERED
MARKETING STATUS
Discontinued
Products
NASALIDE · ReferenceDiscontinued
FLUNISOLIDE 0.025MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SPRAY, METERED · NASAL
Approval history
2007-12-07Labeling · Supplement 26 · standardAP
2007-12-07Labeling · Supplement 18AP
2007-12-07Labeling · Supplement 16AP
2002-08-23Manufacturing (CMC) · Supplement 37 · priorityAP
2000-09-13Manufacturing (CMC) · Supplement 33 · priorityAP
2000-06-29Manufacturing (CMC) · Supplement 32 · priorityAP
1999-02-05Manufacturing (CMC) · Supplement 29 · priorityAP
1998-04-21Manufacturing (CMC) · Supplement 28 · priorityAP
1996-08-02Manufacturing (CMC) · Supplement 27 · priorityAP
1994-08-17Manufacturing (CMC) · Supplement 24 · priorityAP
1994-08-05Manufacturing (CMC) · Supplement 25 · priorityAP
1989-08-25Manufacturing (CMC) · Supplement 14 · priorityAP
1989-03-07Manufacturing (CMC) · Supplement 22 · priorityAP
1989-02-08Labeling · Supplement 21AP
1987-12-23Manufacturing (CMC) · Supplement 20 · priorityAP
1986-09-19Labeling · Supplement 15AP
1986-08-19Manufacturing (CMC) · Supplement 11 · priorityAP
1986-04-21Manufacturing (CMC) · Supplement 7 · priorityAP
1985-09-23Labeling · Supplement 12AP
1985-07-11Labeling · Supplement 13AP
1985-02-21Manufacturing (CMC) · Supplement 8 · priorityAP
1984-03-13Labeling · Supplement 10AP
1983-09-09Manufacturing (CMC) · Supplement 3 · priorityAP
1983-09-09Manufacturing (CMC) · Supplement 4 · priorityAP
1983-09-09Manufacturing (CMC) · Supplement 2 · priorityAP
1983-09-09Manufacturing (CMC) · Supplement 5 · priorityAP
1983-08-30Labeling · Supplement 1AP
1983-06-22Labeling · Supplement 6AP
1981-09-24Type 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.