APPLICATION
NDA014694
TYPE
NDA
ORIGINAL APPROVAL
1964-12-04
LATEST ACTION
2024-06-05
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
HEXADROLDiscontinued
DEXAMETHASONE SODIUM PHOSPHATE EQ 20MG PHOSPHATE/ML · INJECTABLE · INJECTION
HEXADROL · 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SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
HEXADROL · ReferenceDiscontinued
DEXAMETHASONE SODIUM PHOSPHATE EQ 10MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
1995-11-08Labeling · Supplement 28 · standardAP
1995-08-02Manufacturing (CMC) · Supplement 27 · standardAP
1994-02-28Manufacturing (CMC) · Supplement 26 · standardAP
1992-03-24Manufacturing (CMC) · Supplement 25 · standardAP
1988-03-28Labeling · Supplement 24AP
1987-06-02Manufacturing (CMC) · Supplement 23 · standardAP
1985-02-21Labeling · Supplement 21AP
1984-01-23Manufacturing (CMC) · Supplement 18 · standardAP
1981-04-27Manufacturing (CMC) · Supplement 17 · standardAP
1981-04-27Manufacturing (CMC) · Supplement 15 · 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.