APPLICATION
NDA012731
TYPE
NDA
ORIGINAL APPROVAL
1961-03-29
LATEST ACTION
1991-11-29
ROUTE
TOPICAL
DOSAGE FORM
AEROSOL
MARKETING STATUS
Discontinued
Products
DECASPRAY · ReferenceDiscontinued
DEXAMETHASONE 0.04% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · AEROSOL · TOPICAL
Approval history
1991-11-29Manufacturing (CMC) · Supplement 15 · standardAP
1988-07-08Manufacturing (CMC) · Supplement 12 · standardAP
1984-09-24Manufacturing (CMC) · Supplement 10 · standardAP
1984-09-05Labeling · Supplement 11 · standardAP
1979-02-02Manufacturing (CMC) · Supplement 7 · standardAP
1961-03-29Type 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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