APPLICATION
ANDA088149
TYPE
ANDA
ORIGINAL APPROVAL
1983-04-28
LATEST ACTION
2024-06-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
DEXAMETHASONEPrescription
DEXAMETHASONE 0.25MG · TABLET · ORAL
Approval history
2024-06-25Labeling · Supplement 28 · standardAP
2024-06-24Labeling · Supplement 27 · standardAP
1997-11-26Manufacturing (CMC) · Supplement 24AP
1997-11-26Manufacturing (CMC) · Supplement 25AP
1997-08-12Manufacturing (CMC) · Supplement 23AP
1995-10-30Labeling · Supplement 22AP
1994-04-28Labeling · Supplement 21AP
1992-04-29Labeling · Supplement 20AP
1990-09-18Labeling · Supplement 19AP
1990-01-23Labeling · Supplement 18AP
1989-07-31Labeling · Supplement 17AP
1988-09-16Manufacturing (CMC) · Supplement 16AP
1986-05-01Manufacturing (CMC) · Supplement 14AP
1986-05-01Manufacturing (CMC) · Supplement 12AP
1984-02-27Manufacturing (CMC) · Supplement 6AP
1984-02-27Manufacturing (CMC) · Supplement 2AP
1984-02-27Manufacturing (CMC) · Supplement 5AP
1984-02-27Manufacturing (CMC) · Supplement 3AP
1983-12-20Manufacturing (CMC) · Supplement 9AP
1983-10-07Manufacturing (CMC) · Supplement 7AP
1983-04-28OriginalAP
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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