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FDA ANDA · ANDA074087

CLOBETASOL PROPIONATE

Sponsor: TEVA PHARMS USA

APPLICATION
ANDA074087
TYPE
ANDA
ORIGINAL APPROVAL
1994-02-16
LATEST ACTION
2004-11-26
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued

Products

CLOBETASOL PROPIONATEDiscontinued
CLOBETASOL PROPIONATE 0.05% · CREAM · TOPICAL

Approval history

2004-11-26Labeling · Supplement 20AP
2002-01-24Manufacturing (CMC) · Supplement 14AP
2002-01-24Manufacturing (CMC) · Supplement 13AP
2002-01-23Manufacturing (CMC) · Supplement 12AP
2001-10-31Manufacturing (CMC) · Supplement 16AP
2001-10-31Manufacturing (CMC) · Supplement 17AP
2001-10-31Manufacturing (CMC) · Supplement 15AP
2001-02-26Manufacturing (CMC) · Supplement 11AP
1999-03-23Manufacturing (CMC) · Supplement 10AP
1997-09-09Labeling · Supplement 9AP
1997-03-27Labeling · Supplement 8AP
1996-06-13Labeling · Supplement 7AP
1996-05-31Manufacturing (CMC) · Supplement 4AP
1996-04-18Manufacturing (CMC) · Supplement 6AP
1995-11-28Manufacturing (CMC) · Supplement 3AP
1995-03-01Manufacturing (CMC) · Supplement 2AP
1994-02-16OriginalAP
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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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