APPLICATION
ANDA088481
TYPE
ANDA
ORIGINAL APPROVAL
1983-12-15
LATEST ACTION
2024-06-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
DEXAMETHASONEPrescription
DEXAMETHASONE 0.75MG · TABLET · ORAL
DEXAMETHASONEPrescription
DEXAMETHASONE 6MG · TABLET · ORAL
DEXAMETHASONEPrescription
DEXAMETHASONE 4MG · TABLET · ORAL
DEXAMETHASONEPrescription
DEXAMETHASONE 0.5MG · TABLET · ORAL
Approval history
2024-06-05Labeling · Supplement 32 · standardAP
2022-01-14Manufacturing (CMC) · Supplement 27 · unknownAP
2008-07-24Labeling · Supplement 22AP
2002-12-06Manufacturing (CMC) · Supplement 20AP
1997-11-26Manufacturing (CMC) · Supplement 18AP
1997-11-26Manufacturing (CMC) · Supplement 19AP
1997-08-12Manufacturing (CMC) · Supplement 17AP
1995-10-30Labeling · Supplement 16AP
1994-04-28Labeling · Supplement 15AP
1992-04-29Labeling · Supplement 14AP
1990-09-18Labeling · Supplement 13AP
1990-01-23Labeling · Supplement 12AP
1989-07-31Labeling · Supplement 11AP
1988-09-16Manufacturing (CMC) · Supplement 10AP
1986-05-01Manufacturing (CMC) · Supplement 8AP
1986-05-01Manufacturing (CMC) · Supplement 6AP
1984-03-26Manufacturing (CMC) · Supplement 1AP
1984-03-26Manufacturing (CMC) · Supplement 2AP
1983-12-15OriginalAP
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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