APPLICATION
ANDA084764
TYPE
ANDA
ORIGINAL APPROVAL
1978-03-23
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 34 · standardAP
1998-12-01Manufacturing (CMC) · Supplement 33AP
1994-12-23Manufacturing (CMC) · Supplement 32AP
1994-10-11Manufacturing (CMC) · Supplement 31AP
1992-04-03Manufacturing (CMC) · Supplement 28AP
1992-04-03Manufacturing (CMC) · Supplement 30AP
1991-06-28Labeling · Supplement 27AP
1991-01-23Labeling · Supplement 26AP
1990-04-02Labeling · Supplement 25AP
1987-08-13Manufacturing (CMC) · Supplement 23AP
1987-08-13Manufacturing (CMC) · Supplement 22AP
1987-03-20Manufacturing (CMC) · Supplement 21AP
1984-11-09Manufacturing (CMC) · Supplement 17AP
1984-11-09Manufacturing (CMC) · Supplement 16AP
1983-08-16Manufacturing (CMC) · Supplement 15AP
1983-08-16Manufacturing (CMC) · Supplement 14AP
1982-03-11Manufacturing (CMC) · Supplement 10AP
1978-03-23OriginalAP
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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