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FDA ANDA · ANDA074139

CLOBETASOL PROPIONATE

Sponsor: COSETTE PHARMS NC

APPLICATION
ANDA074139
TYPE
ANDA
ORIGINAL APPROVAL
1994-08-03
LATEST ACTION
2005-04-08
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued

Products

CLOBETASOL PROPIONATEDiscontinued
CLOBETASOL PROPIONATE 0.05% · CREAM · TOPICAL

Approval history

2005-04-08Labeling · Supplement 17AP
2002-10-02Manufacturing (CMC) · Supplement 16AP
2002-05-31Manufacturing (CMC) · Supplement 12AP
2002-05-31Manufacturing (CMC) · Supplement 11AP
2001-09-28Labeling · Supplement 14AP
2001-09-28Manufacturing (CMC) · Supplement 15AP
2001-09-28Manufacturing (CMC) · Supplement 13AP
2000-12-29Manufacturing (CMC) · Supplement 10AP
1999-08-18Manufacturing (CMC) · Supplement 9AP
1998-01-07Labeling · Supplement 8AP
1996-08-16Manufacturing (CMC) · Supplement 6AP
1996-08-16Manufacturing (CMC) · Supplement 4AP
1996-08-16Manufacturing (CMC) · Supplement 5AP
1996-08-16Manufacturing (CMC) · Supplement 3AP
1996-06-28Manufacturing (CMC) · Supplement 7AP
1995-12-05Manufacturing (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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