APPLICATION
ANDA088248
TYPE
ANDA
ORIGINAL APPROVAL
1983-09-01
LATEST ACTION
2024-06-05
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
DEXAMETHASONE · ReferencePrescription
DEXAMETHASONE 0.5MG/5ML · SOLUTION · ORAL
Approval history
2024-06-05Labeling · Supplement 27 · standardAP
2021-09-30Labeling · Supplement 26 · standardAP
2005-07-27Labeling · Supplement 20AP
1999-09-14Manufacturing (CMC) · Supplement 17AP
1998-12-01Manufacturing (CMC) · Supplement 18AP
1996-08-28Manufacturing (CMC) · Supplement 15AP
1995-11-22Labeling · Supplement 14AP
1995-02-14Labeling · Supplement 13AP
1994-02-08Labeling · Supplement 12AP
1991-08-02Labeling · Supplement 11AP
1991-03-26Labeling · Supplement 10AP
1988-05-16Manufacturing (CMC) · Supplement 7AP
1988-05-16Manufacturing (CMC) · Supplement 8AP
1985-05-22Manufacturing (CMC) · Supplement 5AP
1984-05-01Manufacturing (CMC) · Supplement 2AP
1984-05-01Manufacturing (CMC) · Supplement 3AP
1984-01-31Manufacturing (CMC) · Supplement 1AP
1983-09-01OriginalAP
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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