Treats oropharyngeal candidiasis. ANDA 215641, held by Rising. Clotrimazole.
As of Nov 15, 2026, ANDA 215641 (Clotrimazole), held by Rising, was first approved by FDA on Feb 29, 2024, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Clotrimazole Lozenges are indicated for the local treatment of oropharyngeal candidiasis. The diagnosis 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 |
|---|---|---|---|
| Feb 29, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Clotrimazole10MG · troche/lozenge;oral | Clotrimazole | Rx |
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
