Alosetron Hydrochloride

ANDA 209180, held by Rising. Alosetron Hydrochloride.

As of Nov 15, 2026, ANDA 209180 (Alosetron Hydrochloride), held by Rising, was first approved by FDA on Jan 14, 2019, with 4 approved supplements and 0 published complete response letters.

First approved: Jan 14, 2019
Review: Standard
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Jan 14, 2019	Original application	Approved	None posted

Products

2 strengths and forms


Alosetron HydrochlorideEQ 0.5MG BASE · tablet;oral	Alosetron Hydrochloride	Rx
Alosetron HydrochlorideEQ 1MG BASE · tablet;oral	Alosetron Hydrochloride	Rx

All 5 submissions, including labeling and manufacturing supplements


Sep 8, 2023	Supplement 6REMS	Approved	Letter
May 5, 2022	Supplement 5REMS	Approved	None posted
Oct 18, 2021	Supplement 4REMS	Approved	None posted
Nov 6, 2019	Supplement 1Labeling · Standard review	Approved	None posted
Jan 14, 2019	Original application	Approved	None posted

Identifiers

Application: ANDA 209180
Drugs@FDA: Overview at FDA
Company: Rising Pharmaceuticals

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