APPLICATION
ANDA074089
TYPE
ANDA
ORIGINAL APPROVAL
1994-02-16
LATEST ACTION
2016-01-04
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Prescription
Products
CLOBETASOL PROPIONATEPrescription
CLOBETASOL PROPIONATE 0.05% · OINTMENT · TOPICAL
Approval history
2016-01-04Manufacturing (CMC) · Supplement 24 · unknownAP
2004-11-26Labeling · Supplement 20AP
2002-01-23Manufacturing (CMC) · Supplement 10AP
2001-10-31Manufacturing (CMC) · Supplement 12AP
2001-10-31Manufacturing (CMC) · Supplement 13AP
2001-10-31Manufacturing (CMC) · Supplement 11AP
2001-02-26Manufacturing (CMC) · Supplement 9AP
1999-03-23Manufacturing (CMC) · Supplement 8AP
1997-09-09Labeling · Supplement 7AP
1997-03-27Labeling · Supplement 6AP
1996-06-13Labeling · Supplement 5AP
1996-05-31Manufacturing (CMC) · Supplement 3AP
1996-03-18Manufacturing (CMC) · Supplement 4AP
1996-01-23Manufacturing (CMC) · Supplement 2AP
1994-02-16OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.