APPLICATION
ANDA080399
TYPE
ANDA
ORIGINAL APPROVAL
1971-10-20
LATEST ACTION
2024-06-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, Prescription
Products
DEXAMETHASONEDiscontinued
DEXAMETHASONE 0.75MG · TABLET · ORAL
DEXAMETHASONEPrescription
DEXAMETHASONE 4MG · TABLET · ORAL
Approval history
2024-06-05Labeling · Supplement 80 · standardAP
2022-08-15Manufacturing (CMC) · Supplement 79 · unknownAP
1984-01-20Manufacturing (CMC) · Supplement 75AP
1983-07-27Manufacturing (CMC) · Supplement 74AP
1982-09-27Manufacturing (CMC) · Supplement 72AP
1982-09-27Manufacturing (CMC) · Supplement 70AP
1982-08-03Manufacturing (CMC) · Supplement 73AP
1971-10-20OriginalAP
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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