ANDA 218495, held by Novitium Pharma. Pitolisant Hydrochloride.
As of Nov 15, 2026, ANDA 218495 (Pitolisant Hydrochloride), held by Novitium Pharma, was first approved by FDA on Jul 21, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 21, 2026 | Original application | Approved |
| Pitolisant HydrochlorideEQ 4.45MG BASE · tablet;oral | Pitolisant Hydrochloride | Rx |
| Pitolisant HydrochlorideEQ 17.8MG BASE · tablet;oral | Pitolisant Hydrochloride | 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
