Treats pneumonia due to Pneumocystis carinii. ANDA 206666, held by Pai Holdings. Pentamidine Isethionate.
As of Nov 15, 2026, ANDA 206666 (Pentamidine Isethionate), held by Pai Holdings, was first approved by FDA on Sep 28, 2017, 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 |
|---|---|---|---|
| Sep 28, 2017 | 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
