APPLICATION
NDA019048
TYPE
NDA
ORIGINAL APPROVAL
1984-12-14
LATEST ACTION
2013-03-13
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription
Products
DESOWENPrescription
DESONIDE 0.05% · CREAM · TOPICAL
Approval history
2013-03-13Manufacturing (CMC) · Supplement 15 · standardAP
1995-05-11Labeling · Supplement 12 · standardAP
1994-01-18Manufacturing (CMC) · Supplement 11 · standardAP
1993-09-30Manufacturing (CMC) · Supplement 9 · standardAP
1993-08-03Manufacturing (CMC) · Supplement 10 · standardAP
1991-08-30Labeling · Supplement 7AP
1989-08-28Manufacturing (CMC) · Supplement 5 · standardAP
1989-08-18Manufacturing (CMC) · Supplement 6 · standardAP
1988-11-23Labeling · Supplement 4AP
1985-10-25Manufacturing (CMC) · Supplement 3 · standardAP
1985-06-26Manufacturing (CMC) · Supplement 2 · standardAP
1985-06-14Labeling · Supplement 1AP
1984-12-14Type 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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