APPLICATION
ANDA072488
TYPE
ANDA
ORIGINAL APPROVAL
1989-02-06
LATEST ACTION
2001-08-30
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription
Products
FLUOCINONIDEPrescription
FLUOCINONIDE 0.05% · CREAM · TOPICAL
Approval history
2001-08-30Manufacturing (CMC) · Supplement 21AP
2000-07-07Manufacturing (CMC) · Supplement 20AP
2000-02-17Manufacturing (CMC) · Supplement 19AP
1997-04-09Labeling · Supplement 18AP
1996-06-13Manufacturing (CMC) · Supplement 17AP
1995-08-07Manufacturing (CMC) · Supplement 16AP
1995-05-04Manufacturing (CMC) · Supplement 15AP
1995-05-04Manufacturing (CMC) · Supplement 13AP
1995-05-04Manufacturing (CMC) · Supplement 14AP
1995-05-04Manufacturing (CMC) · Supplement 12AP
1995-02-13Manufacturing (CMC) · Supplement 9AP
1995-02-13Manufacturing (CMC) · Supplement 11AP
1995-02-13Manufacturing (CMC) · Supplement 7AP
1995-02-13Manufacturing (CMC) · Supplement 8AP
1995-02-13Manufacturing (CMC) · Supplement 10AP
1993-08-31Manufacturing (CMC) · Supplement 5AP
1993-08-31Manufacturing (CMC) · Supplement 6AP
1993-04-01Manufacturing (CMC) · Supplement 4AP
1992-10-13Manufacturing (CMC) · Supplement 1AP
1991-09-30Manufacturing (CMC) · Supplement 3AP
1989-02-06OriginalAP
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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