APPLICATION
ANDA087711
TYPE
ANDA
ORIGINAL APPROVAL
1982-05-24
LATEST ACTION
2014-12-02
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
DEXAMETHASONE ACETATEDiscontinued
DEXAMETHASONE ACETATE EQ 16MG BASE/ML · INJECTABLE · INJECTION
Approval history
2014-12-02Labeling · Supplement 28 · standardAP
1999-02-19Manufacturing (CMC) · Supplement 26AP
1999-02-02Manufacturing (CMC) · Supplement 25AP
1998-05-22Manufacturing (CMC) · Supplement 24AP
1996-07-24Manufacturing (CMC) · Supplement 23AP
1994-11-30Labeling · Supplement 22AP
1994-08-08Labeling · Supplement 20AP
1993-12-20Manufacturing (CMC) · Supplement 21AP
1992-05-11Manufacturing (CMC) · Supplement 19AP
1992-02-25Labeling · Supplement 14AP
1991-03-21Manufacturing (CMC) · Supplement 12AP
1991-03-21Manufacturing (CMC) · Supplement 13AP
1991-03-21Manufacturing (CMC) · Supplement 11AP
1991-01-11Manufacturing (CMC) · Supplement 18AP
1989-07-14Manufacturing (CMC) · Supplement 16AP
1989-07-14Manufacturing (CMC) · Supplement 15AP
1988-12-19Labeling · Supplement 10AP
1986-06-16Manufacturing (CMC) · Supplement 5AP
1984-12-10Manufacturing (CMC) · Supplement 3AP
1983-08-31Manufacturing (CMC) · Supplement 2AP
1983-06-08Manufacturing (CMC) · Supplement 1AP
1982-05-24OriginalAP
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.