APPLICATION
ANDA074580
TYPE
ANDA
ORIGINAL APPROVAL
1996-07-29
LATEST ACTION
2003-09-11
ROUTE
TOPICAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
CLOTRIMAZOLEPrescription
CLOTRIMAZOLE 1% · SOLUTION · TOPICAL
Approval history
2003-09-11Labeling · Supplement 6AP
2002-11-04Manufacturing (CMC) · Supplement 4AP
2001-01-18Manufacturing (CMC) · Supplement 3AP
1997-12-08Manufacturing (CMC) · Supplement 2AP
1996-07-29OriginalAP
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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