APPLICATION
ANDA074165
TYPE
ANDA
ORIGINAL APPROVAL
1993-07-16
LATEST ACTION
2022-03-10
ROUTE
VAGINAL
DOSAGE FORM
CREAM
MARKETING STATUS
Over-the-counter
Products
CLOTRIMAZOLEOver-the-counter
CLOTRIMAZOLE 1% · CREAM · VAGINAL
Approval history
2022-03-10Labeling · Supplement 43 · standardAP
2015-11-09Manufacturing (CMC) · Supplement 39 · unknownAP
2015-04-14Labeling · Supplement 37 · standardAP
2015-04-14Labeling · Supplement 33AP
2015-01-05Manufacturing (CMC) · Supplement 38 · unknownAP
2001-07-10Manufacturing (CMC) · Supplement 20AP
2000-12-29Manufacturing (CMC) · Supplement 19AP
1999-11-15Manufacturing (CMC) · Supplement 17AP
1999-11-15Labeling · Supplement 18AP
1999-11-15Manufacturing (CMC) · Supplement 16AP
1999-05-13Manufacturing (CMC) · Supplement 15AP
1998-04-01Manufacturing (CMC) · Supplement 14AP
1997-09-11Labeling · Supplement 12AP
1996-06-28Manufacturing (CMC) · Supplement 11AP
1996-05-30Manufacturing (CMC) · Supplement 9AP
1996-05-30Manufacturing (CMC) · Supplement 7AP
1996-05-30Manufacturing (CMC) · Supplement 8AP
1996-05-30Manufacturing (CMC) · Supplement 10AP
1996-04-24Labeling · Supplement 5AP
1996-02-07Manufacturing (CMC) · Supplement 6AP
1994-10-19Labeling · Supplement 4AP
1994-03-24Labeling · Supplement 1AP
1993-12-20Manufacturing (CMC) · Supplement 2AP
1993-12-10Manufacturing (CMC) · Supplement 3AP
1993-07-16OriginalAP
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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