APPLICATION
ANDA088254
TYPE
ANDA
ORIGINAL APPROVAL
1983-07-27
LATEST ACTION
2024-06-05
ROUTE
ORAL
DOSAGE FORM
ELIXIR
MARKETING STATUS
Discontinued
Products
DEXAMETHASONE · ReferenceDiscontinued
DEXAMETHASONE 0.5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · ELIXIR · ORAL
Approval history
2024-06-05Labeling · Supplement 21 · standardAP
2015-02-06Labeling · Supplement 15AP
1995-02-03Labeling · Supplement 13AP
1993-12-23Labeling · Supplement 12AP
1993-12-23Labeling · Supplement 11AP
1990-12-31Labeling · Supplement 10AP
1989-12-06Labeling · Supplement 9AP
1987-05-18Manufacturing (CMC) · Supplement 8AP
1987-05-18Manufacturing (CMC) · Supplement 7AP
1986-05-22Manufacturing (CMC) · Supplement 6AP
1984-06-08Manufacturing (CMC) · Supplement 3AP
1984-05-22Manufacturing (CMC) · Supplement 2AP
1984-02-01Manufacturing (CMC) · Supplement 1AP
1983-07-27OriginalAP
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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