APPLICATION
ANDA088316
TYPE
ANDA
ORIGINAL APPROVAL
1983-09-15
LATEST ACTION
2024-06-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
DEXAMETHASONE · ReferencePrescription
DEXAMETHASONE 6MG · TABLET · ORAL
Approval history
2024-06-05Labeling · Supplement 26 · standardAP
2021-09-30Labeling · Supplement 25 · standardAP
2008-12-01Labeling · Supplement 23AP
2005-07-27Labeling · Supplement 22AP
2001-10-30Manufacturing (CMC) · Supplement 20AP
1996-08-28Manufacturing (CMC) · Supplement 16AP
1995-11-22Labeling · Supplement 15AP
1995-05-31Manufacturing (CMC) · Supplement 14AP
1995-02-14Labeling · Supplement 13AP
1994-02-08Labeling · Supplement 12AP
1992-01-06Labeling · Supplement 11AP
1991-05-30Manufacturing (CMC) · Supplement 8AP
1990-11-30Labeling · Supplement 10AP
1990-01-24Labeling · Supplement 9AP
1988-06-03Manufacturing (CMC) · Supplement 6AP
1988-06-03Manufacturing (CMC) · Supplement 7AP
1985-05-21Manufacturing (CMC) · Supplement 4AP
1984-04-17Manufacturing (CMC) · Supplement 2AP
1984-01-31Manufacturing (CMC) · Supplement 1AP
1983-09-15OriginalAP
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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