Treats pneumonia due to Pneumocystis carinii. ANDA 213806, held by Avet Lifesciences. Pentamidine Isethionate.
As of Nov 15, 2026, ANDA 213806 (Pentamidine Isethionate), held by Avet Lifesciences, was first approved by FDA on Jan 7, 2021, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Pentamidine isethionate for injection is indicated for the treatment of pneumonia due to Pneumocystis carinii.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 7, 2021 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pentamidine Isethionate300MG/VIAL · injectable;injection | Pentamidine Isethionate | 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
