Treats oropharyngeal candidiasis. ANDA 76387, held by Hikma. Clotrimazole.
As of Nov 15, 2026, ANDA 76387 (Clotrimazole), held by Hikma, was first approved by FDA on Jul 29, 2004, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Clotrimazole is indicated for the local treatment of oropharyngeal candidiasis. The diagnosis should be confirmed by a KOH smear and/or culture prior to treatment. Clotrimazole is 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. There are no data from adequate and well-controlled trials to establish the safety and efficacy of this product for prophylactic use in patients immunocompromised by etiologies other than those listed in the previous sentence.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 29, 2004 | Original application | Approved |
| 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
