APPLICATION
NDA018182
TYPE
NDA
ORIGINAL APPROVAL
1979-02-27
LATEST ACTION
2001-09-07
ROUTE
VAGINAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
MYCELEX-7Discontinued
CLOTRIMAZOLE 100MG · TABLET · VAGINAL
Approval history
2001-09-07Manufacturing (CMC) · Supplement 17 · standardAP
2000-02-10Manufacturing (CMC) · Supplement 16 · standardAP
1993-05-24Labeling · Supplement 12 · standardAP
1993-02-22Manufacturing (CMC) · Supplement 10 · standardAP
1992-10-08Labeling · Supplement 11AP
1991-12-26Efficacy · Supplement 9AP
1990-11-15Labeling · Supplement 8AP
1987-06-03Manufacturing (CMC) · Supplement 7 · standardAP
1982-01-28Labeling · Supplement 5AP
1981-01-09Manufacturing (CMC) · Supplement 2 · standardAP
1980-08-05Labeling · Supplement 1AP
1979-02-27Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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