APPLICATION
NDA012071
TYPE
NDA
ORIGINAL APPROVAL
1959-10-06
LATEST ACTION
2000-02-18
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DECADRON · ReferenceDiscontinued
DEXAMETHASONE SODIUM PHOSPHATE EQ 24MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
DECADRON · ReferenceDiscontinued
DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2000-02-18Manufacturing (CMC) · Supplement 53 · standardAP
1999-02-17Manufacturing (CMC) · Supplement 46 · standardAP
1997-10-22Manufacturing (CMC) · Supplement 49 · standardAP
1997-09-09Manufacturing (CMC) · Supplement 47 · standardAP
1996-03-01Manufacturing (CMC) · Supplement 43 · standardAP
1993-08-26Labeling · Supplement 39 · standardAP
1989-12-11Manufacturing (CMC) · Supplement 38 · standardAP
1985-03-08Labeling · Supplement 31 · standardAP
1984-06-25Manufacturing (CMC) · Supplement 30 · standardAP
1981-02-05Manufacturing (CMC) · Supplement 23 · standardAP
1979-08-15Labeling · Supplement 26 · standardAP
1978-10-18Labeling · Supplement 25 · standardAP
1959-10-06Type 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.