APPLICATION
ANDA074221
TYPE
ANDA
ORIGINAL APPROVAL
1995-03-31
LATEST ACTION
2019-02-13
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued
Products
EMBELINEDiscontinued
CLOBETASOL PROPIONATE 0.05% · OINTMENT · TOPICAL
Approval history
2019-02-13Manufacturing (CMC) · Supplement 8AP
2000-06-27Manufacturing (CMC) · Supplement 6AP
1999-01-21Manufacturing (CMC) · Supplement 5AP
1998-11-05Manufacturing (CMC) · Supplement 3AP
1998-11-05Manufacturing (CMC) · Supplement 1AP
1998-11-05Labeling · Supplement 4AP
1998-11-05Manufacturing (CMC) · Supplement 2AP
1995-03-31OriginalAP
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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