APPLICATION
NDA012674
TYPE
NDA
ORIGINAL APPROVAL
1960-12-21
LATEST ACTION
2024-06-05
ROUTE
ORAL
DOSAGE FORM
ELIXIR
MARKETING STATUS
Discontinued
Products
HEXADROLDiscontinued
DEXAMETHASONE 0.5MG/5ML · ELIXIR · ORAL
Approval history
1989-05-11Manufacturing (CMC) · Supplement 8 · standardAP
1987-06-02Manufacturing (CMC) · Supplement 9 · standardAP
1984-06-18Manufacturing (CMC) · Supplement 7 · standardAP
1960-12-21Type 5 - New Formulation or New Manufacturer · 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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