APPLICATION
ANDA084765
TYPE
ANDA
ORIGINAL APPROVAL
1978-03-23
LATEST ACTION
2024-06-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
DEXAMETHASONEDiscontinued
DEXAMETHASONE 0.75MG · 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
1991-07-02Labeling · Supplement 23AP
1991-02-07Labeling · Supplement 22AP
1990-04-02Labeling · Supplement 21AP
1987-10-30Manufacturing (CMC) · Supplement 18AP
1987-10-30Manufacturing (CMC) · Supplement 19AP
1987-03-20Manufacturing (CMC) · Supplement 17AP
1985-08-21Manufacturing (CMC) · Supplement 13AP
1984-08-24Manufacturing (CMC) · Supplement 12AP
1984-08-24Manufacturing (CMC) · Supplement 11AP
1982-03-11Manufacturing (CMC) · Supplement 7AP
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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