APPLICATION
NDA012376
TYPE
NDA
ORIGINAL APPROVAL
1960-07-07
LATEST ACTION
1993-08-27
ROUTE
ORAL
DOSAGE FORM
ELIXIR
MARKETING STATUS
Discontinued
Products
DECADRONDiscontinued
DEXAMETHASONE 0.5MG/5ML · ELIXIR · ORAL
Approval history
1993-08-27Labeling · Supplement 28 · standardAP
1989-05-16Labeling · Supplement 22 · standardAP
1989-01-12Manufacturing (CMC) · Supplement 25 · standardAP
1982-05-21Labeling · Supplement 18 · standardAP
1982-02-10Manufacturing (CMC) · Supplement 19 · standardAP
1979-08-15Labeling · Supplement 17 · standardAP
1979-03-01Manufacturing (CMC) · Supplement 16 · standardAP
1960-07-07Type 3 - New Dosage Form · Original · standardAP
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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