APPLICATION
ANDA074248
TYPE
ANDA
ORIGINAL APPROVAL
1996-07-12
LATEST ACTION
2019-09-06
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Prescription
Products
CLOBETASOL PROPIONATEPrescription
CLOBETASOL PROPIONATE 0.05% · OINTMENT · TOPICAL
Approval history
2019-09-06Labeling · Supplement 24 · standardAP
2003-11-07Labeling · Supplement 16AP
2002-12-09Manufacturing (CMC) · Supplement 9AP
2002-12-09Manufacturing (CMC) · Supplement 10AP
2002-07-11Manufacturing (CMC) · Supplement 11AP
2000-04-06Manufacturing (CMC) · Supplement 8AP
1999-02-11Manufacturing (CMC) · Supplement 7AP
1998-01-16Labeling · Supplement 5AP
1998-01-16Manufacturing (CMC) · Supplement 3AP
1998-01-16Manufacturing (CMC) · Supplement 1AP
1998-01-16Manufacturing (CMC) · Supplement 4AP
1998-01-16Manufacturing (CMC) · Supplement 2AP
1997-08-19Manufacturing (CMC) · Supplement 6AP
1996-07-12OriginalAP
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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