ANDA 208591, held by Alkem Labs Ltd. Itraconazole.
As of Nov 15, 2026, ANDA 208591 (Itraconazole), held by Alkem Labs Ltd, was first approved by FDA on Jun 12, 2017, with 7 approved supplements and 0 published complete response letters.
INDICATIONS & USAGE Itraconazole capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients: 1. Blastomycosis, pulmonary and extrapulmonary 2. Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis, and 3. Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy. Specimens for fungal cultures and other relevant laboratory studies (wet mount, histopathology, serology) should be obtained before therapy to isolate and identify causative organisms.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 12, 2017 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Itraconazole100MG · capsule;oral | Itraconazole | Rx |
| Mar 12, 2025 | Supplement 13Labeling · Standard review | Approved | None posted |
| Mar 12, 2025 | Supplement 14Labeling · Standard review | Approved | None posted |
| Jun 10, 2024 | Supplement 10Labeling · Standard review | Approved | None posted |
| May 4, 2023 | Supplement 9Labeling · Standard review | Approved | None posted |
| Oct 11, 2019 | Supplement 2Labeling · Standard review | Approved | None posted |
| Oct 11, 2019 | Supplement 3Labeling · Standard review | Approved | None posted |
| Oct 11, 2019 | Supplement 4Labeling · Standard review | Approved | None posted |
| Jun 12, 2017 | 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
