APPLICATION
ANDA072641
TYPE
ANDA
ORIGINAL APPROVAL
1995-12-04
LATEST ACTION
2002-11-04
ROUTE
VAGINAL
DOSAGE FORM
CREAM
MARKETING STATUS
Over-the-counter
Products
CLOTRIMAZOLEOver-the-counter
CLOTRIMAZOLE 1% · CREAM · VAGINAL
Approval history
2002-11-04Manufacturing (CMC) · Supplement 18AP
2001-10-15Manufacturing (CMC) · Supplement 16AP
2001-10-15Manufacturing (CMC) · Supplement 17AP
2000-11-20Manufacturing (CMC) · Supplement 14AP
2000-11-20Manufacturing (CMC) · Supplement 15AP
2000-03-14Manufacturing (CMC) · Supplement 12AP
2000-03-14Manufacturing (CMC) · Supplement 10AP
2000-03-14Manufacturing (CMC) · Supplement 13AP
2000-03-14Manufacturing (CMC) · Supplement 11AP
1998-01-29Manufacturing (CMC) · Supplement 9AP
1997-12-08Manufacturing (CMC) · Supplement 8AP
1997-09-30Manufacturing (CMC) · Supplement 6AP
1997-03-25Manufacturing (CMC) · Supplement 3AP
1997-03-25Manufacturing (CMC) · Supplement 4AP
1997-01-07Manufacturing (CMC) · Supplement 2AP
1996-09-17Manufacturing (CMC) · Supplement 1AP
1995-12-04OriginalAP
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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