APPLICATION
NDA017426
TYPE
NDA
ORIGINAL APPROVAL
1974-11-01
LATEST ACTION
2016-06-08
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Prescription
Products
DESONIDE · ReferencePrescription
DESONIDE 0.05% · OINTMENT · TOPICAL
Approval history
2016-06-08Manufacturing (CMC) · Supplement 20 · standardAP
2000-08-31Manufacturing (CMC) · Supplement 16 · standardAP
1997-08-08Manufacturing (CMC) · Supplement 15 · standardAP
1995-06-12Labeling · Supplement 14 · standardAP
1990-05-15Labeling · Supplement 13AP
1988-02-04Manufacturing (CMC) · Supplement 12 · standardAP
1986-07-22Labeling · Supplement 11AP
1983-03-28Manufacturing (CMC) · Supplement 10 · standardAP
1983-01-05Manufacturing (CMC) · Supplement 9 · standardAP
1982-12-06Labeling · Supplement 5AP
1982-11-01Manufacturing (CMC) · Supplement 8 · standardAP
1981-03-13Manufacturing (CMC) · Supplement 6 · standardAP
1980-12-16Manufacturing (CMC) · Supplement 4 · standardAP
1980-05-01Manufacturing (CMC) · Supplement 3 · standardAP
1979-04-19Labeling · Supplement 2AP
1979-04-13Manufacturing (CMC) · Supplement 1 · standardAP
1974-11-01Type 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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