APPLICATION
ANDA089524
TYPE
ANDA
ORIGINAL APPROVAL
1988-07-26
LATEST ACTION
2017-09-10
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Prescription
Products
FLUOCINOLONE ACETONIDEPrescription
FLUOCINOLONE ACETONIDE 0.025% · OINTMENT · TOPICAL
Approval history
2017-09-10Manufacturing (CMC) · Supplement 8AP
1999-01-08Manufacturing (CMC) · Supplement 4AP
1993-01-29Manufacturing (CMC) · Supplement 3AP
1991-05-14Manufacturing (CMC) · Supplement 1AP
1991-01-25Manufacturing (CMC) · Supplement 2AP
1988-07-26OriginalAP
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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