APPLICATION
ANDA085458
TYPE
ANDA
ORIGINAL APPROVAL
1977-02-08
LATEST ACTION
1996-04-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
DEXAMETHASONEDiscontinued
DEXAMETHASONE 0.5MG · TABLET · ORAL
Approval history
1996-04-17Labeling · Supplement 18AP
1994-02-09Labeling · Supplement 17AP
1991-08-12Manufacturing (CMC) · Supplement 14AP
1991-05-31Manufacturing (CMC) · Supplement 12AP
1991-01-28Manufacturing (CMC) · Supplement 13AP
1991-01-04Labeling · Supplement 16AP
1990-06-15Labeling · Supplement 15AP
1990-04-02Labeling · Supplement 11AP
1977-02-08OriginalAP
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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