APPLICATION
NDA013413
TYPE
NDA
ORIGINAL APPROVAL
1962-09-17
LATEST ACTION
1995-07-10
ROUTE
INHALATION
DOSAGE FORM
AEROSOL, METERED
MARKETING STATUS
Discontinued
Products
DEXACORTDiscontinued
DEXAMETHASONE SODIUM PHOSPHATE EQ 0.1MG PHOSPHATE/INH · AEROSOL, METERED · INHALATION
Approval history
1995-07-10Manufacturing (CMC) · Supplement 30 · standardAP
1994-05-03Labeling · Supplement 26 · standardAP
1991-09-11Manufacturing (CMC) · Supplement 25 · standardAP
1989-05-18Labeling · Supplement 21 · standardAP
1979-08-15Labeling · Supplement 15 · standardAP
1979-08-06Labeling · Supplement 14 · standardAP
1962-09-17Type 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.