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FDA ANDA · ANDA074128

CLOBETASOL PROPIONATE

Sponsor: ACTAVIS MID ATLANTIC

APPLICATION
ANDA074128
TYPE
ANDA
ORIGINAL APPROVAL
1994-08-03
LATEST ACTION
2004-05-18
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued

Products

CLOBETASOL PROPIONATEDiscontinued
CLOBETASOL PROPIONATE 0.05% · OINTMENT · TOPICAL

Approval history

2004-05-18Labeling · Supplement 16AP
2002-08-29Labeling · Supplement 13AP
2002-08-29Manufacturing (CMC) · Supplement 12AP
2002-05-31Manufacturing (CMC) · Supplement 11AP
2002-05-31Manufacturing (CMC) · Supplement 10AP
2001-05-30Manufacturing (CMC) · Supplement 14AP
2000-12-29Manufacturing (CMC) · Supplement 9AP
1998-01-07Labeling · Supplement 8AP
1996-08-15Manufacturing (CMC) · Supplement 5AP
1996-08-15Manufacturing (CMC) · Supplement 3AP
1996-08-15Manufacturing (CMC) · Supplement 6AP
1996-08-15Manufacturing (CMC) · Supplement 4AP
1996-06-28Manufacturing (CMC) · Supplement 7AP
1995-12-07Manufacturing (CMC) · Supplement 2AP
1995-03-13Manufacturing (CMC) · Supplement 1AP
1994-08-03OriginalAP
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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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