ANDA 206113, held by Ph Health. Alosetron Hydrochloride.
As of Nov 15, 2026, ANDA 206113 (Alosetron Hydrochloride), held by Ph Health, was first approved by FDA on Feb 23, 2018, with 4 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 23, 2018 | Original application | Approved | None posted |
| Alosetron HydrochlorideEQ 0.5MG BASE · tablet;oral | Alosetron Hydrochloride | Discontinued |
| Alosetron HydrochlorideEQ 1MG BASE · tablet;oral | Alosetron Hydrochloride | Discontinued |
| Sep 8, 2023 | Supplement 6REMS | Approved | |
| May 5, 2022 | Supplement 5REMS | Approved | None posted |
| Oct 18, 2021 | Supplement 4REMS | Approved | None posted |
| Dec 6, 2019 | Supplement 2Labeling · Standard review | Approved | None posted |
| Feb 23, 2018 | Original application | Approved | None posted |
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
