ANDA 218873, held by Msn. Pitolisant Hydrochloride.
As of Nov 15, 2026, ANDA 218873 (Pitolisant Hydrochloride), held by Msn, was first approved by FDA on Aug 14, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 14, 2026 | Original application | Approved | None posted |
| 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
