APPLICATION
ANDA084013
TYPE
ANDA
ORIGINAL APPROVAL
1974-06-21
LATEST ACTION
2024-06-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
DEXAMETHASONEDiscontinued
DEXAMETHASONE 0.25MG · TABLET · ORAL
Approval history
2024-06-05Labeling · Supplement 30 · standardAP
1998-12-01Manufacturing (CMC) · Supplement 29AP
1994-12-23Manufacturing (CMC) · Supplement 28AP
1994-10-11Manufacturing (CMC) · Supplement 27AP
1992-04-03Manufacturing (CMC) · Supplement 26AP
1992-04-03Manufacturing (CMC) · Supplement 24AP
1991-10-22Labeling · Supplement 23AP
1991-01-23Labeling · Supplement 22AP
1990-04-05Labeling · Supplement 21AP
1987-03-20Manufacturing (CMC) · Supplement 19AP
1985-08-21Manufacturing (CMC) · Supplement 18AP
1982-03-11Manufacturing (CMC) · Supplement 17AP
1974-06-21OriginalAP
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.