Treats oropharyngeal candidiasis. ANDA 76763, held by Padagis US. Clotrimazole.
As of Nov 15, 2026, ANDA 76763 (Clotrimazole), held by Padagis US, was first approved by FDA on Oct 28, 2005, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Clotrimazole lozenges are indicated for the local treatment of oropharyngeal candidiasis. The diagnoses should be confirmed by a KOH smear and/or culture prior to treatment. Clotrimazole lozenges are also indicated prophylactically to reduce the incidence of oropharyngeal candidiasis in patients immunocompromised by conditions that include chemotherapy, radiotherapy, or steroid therapy utilized in the treatment of leukemia, solid tumors, or renal transplantation.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 28, 2005 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Clotrimazole10MG · troche/lozenge;oral | Clotrimazole | Rx |
| Sep 10, 2007 | Supplement 6Labeling | Approved | None posted |
| Oct 28, 2005 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
