APPLICATION
ANDA073481
TYPE
ANDA
ORIGINAL APPROVAL
1991-12-27
LATEST ACTION
2001-10-26
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Prescription
Products
FLUOCINONIDEPrescription
FLUOCINONIDE 0.05% · OINTMENT · TOPICAL
Approval history
2001-10-26Manufacturing (CMC) · Supplement 14AP
2001-08-30Manufacturing (CMC) · Supplement 13AP
2000-07-07Manufacturing (CMC) · Supplement 12AP
1999-12-23Manufacturing (CMC) · Supplement 11AP
1998-03-12Manufacturing (CMC) · Supplement 10AP
1996-12-31Labeling · Supplement 9AP
1996-09-24Manufacturing (CMC) · Supplement 7AP
1996-09-24Manufacturing (CMC) · Supplement 6AP
1996-06-13Manufacturing (CMC) · Supplement 8AP
1994-12-14Manufacturing (CMC) · Supplement 5AP
1993-11-23Manufacturing (CMC) · Supplement 3AP
1992-11-24Manufacturing (CMC) · Supplement 2AP
1992-05-08Manufacturing (CMC) · Supplement 1AP
1991-12-27OriginalAP
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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