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FDA ANDA · ANDA074331

CLOBETASOL PROPIONATE

Sponsor: COSETTE PHARMS NC

APPLICATION
ANDA074331
TYPE
ANDA
ORIGINAL APPROVAL
1995-12-15
LATEST ACTION
2004-03-11
ROUTE
TOPICAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

CLOBETASOL PROPIONATEDiscontinued
CLOBETASOL PROPIONATE 0.05% · SOLUTION · TOPICAL

Approval history

2004-03-11Labeling · Supplement 12AP
2002-01-23Manufacturing (CMC) · Supplement 10AP
2000-10-31Manufacturing (CMC) · Supplement 9AP
2000-10-31Manufacturing (CMC) · Supplement 8AP
1997-07-18Manufacturing (CMC) · Supplement 2AP
1997-07-18Manufacturing (CMC) · Supplement 5AP
1997-07-18Manufacturing (CMC) · Supplement 3AP
1997-05-15Manufacturing (CMC) · Supplement 6AP
1997-03-25Manufacturing (CMC) · Supplement 1AP
1995-12-15OriginalAP
VIEW ON DRUGS@FDA ↗

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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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