APPLICATION
ANDA084084
TYPE
ANDA
ORIGINAL APPROVAL
1974-07-10
LATEST ACTION
2024-06-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
DEXAMETHASONEDiscontinued
DEXAMETHASONE 0.5MG · TABLET · ORAL
Approval history
2024-06-05Labeling · Supplement 27 · standardAP
1998-12-01Manufacturing (CMC) · Supplement 26AP
1994-12-23Manufacturing (CMC) · Supplement 25AP
1994-10-11Manufacturing (CMC) · Supplement 24AP
1992-04-03Manufacturing (CMC) · Supplement 23AP
1992-04-03Manufacturing (CMC) · Supplement 21AP
1991-10-23Labeling · Supplement 20AP
1991-03-15Labeling · Supplement 19AP
1990-04-05Labeling · Supplement 18AP
1987-03-20Manufacturing (CMC) · Supplement 16AP
1982-03-11Manufacturing (CMC) · Supplement 14AP
1974-07-10OriginalAP
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.
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