APPLICATION
ANDA074254
TYPE
ANDA
ORIGINAL APPROVAL
1994-08-03
LATEST ACTION
2016-01-15
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Prescription
Products
DESONIDEPrescription
DESONIDE 0.05% · OINTMENT · TOPICAL
Approval history
2016-01-15Labeling · Supplement 10 · standardAP
1998-01-20Manufacturing (CMC) · Supplement 3AP
1997-08-11Manufacturing (CMC) · Supplement 2AP
1996-09-17Manufacturing (CMC) · Supplement 1AP
1994-08-03OriginalAP
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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