Alosetron Hydrochloride

ANDA 200652, held by Hikma. Alosetron Hydrochloride.

As of Nov 15, 2026, ANDA 200652 (Alosetron Hydrochloride), held by Hikma, was first approved by FDA on May 4, 2015, with 7 approved supplements and 0 published complete response letters.

First approved: May 4, 2015
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
May 4, 2015	Original application	Approved	Label Letter

Products

2 strengths and forms


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

All 8 submissions, including labeling and manufacturing supplements


Sep 8, 2023	Supplement 9REMS	Approved	Letter
May 5, 2022	Supplement 8REMS	Approved	None posted
Oct 18, 2021	Supplement 7REMS	Approved	Letter
Dec 6, 2019	Supplement 5Labeling · Standard review	Approved	None posted
Nov 22, 2016	Supplement 4REMS	Approved	Review Letter
Mar 24, 2016	Supplement 3REMS	Approved	None posted
Jan 7, 2016	Supplement 2REMS	Approved	None posted
May 4, 2015	Original application	Approved	Label Letter

Identifiers

Application: ANDA 200652
Drugs@FDA: Overview at FDA
Company: Hikma

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