ANDA 218832, held by Annora Pharma. Pitolisant Hydrochloride.
As of Nov 15, 2026, ANDA 218832 (Pitolisant Hydrochloride), held by Annora Pharma, was first approved by FDA on Oct 8, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 8, 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
