← FDA DRUG APPROVALS

FDA NDA · NDA021107

LOTRONEX

alosetron hydrochloride

Sponsor: LEGACY

APPLICATION
NDA021107
TYPE
NDA
ORIGINAL APPROVAL
2000-02-09
LATEST ACTION
2023-09-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

LOTRONEX · ReferencePrescription
ALOSETRON HYDROCHLORIDE EQ 0.5MG BASE · TABLET · ORAL
LOTRONEX · ReferencePrescription
ALOSETRON HYDROCHLORIDE EQ 1MG BASE · TABLET · ORAL

Approval history

2023-09-08REMS · Supplement 30 — Letter ↗AP
2019-04-03Labeling · Supplement 29 · standard — Label ↗AP
2016-01-07REMS · Supplement 26 — Review ↗AP
2016-01-07Labeling · Supplement 27 · standard — Label ↗AP
2015-07-24REMS · Supplement 25 — Letter ↗AP
2014-05-08REMS · Supplement 24 — Letter ↗AP
2013-04-19Manufacturing (CMC) · Supplement 21 · priorityAP
2010-09-02Labeling · Supplement 16 · unknown — Letter ↗AP
2010-09-02Labeling · Supplement 14 · standard — Letter ↗AP
2008-04-01Efficacy · Supplement 13 · unknown — Letter ↗AP
2006-03-10Labeling · Supplement 12 · standard — Label ↗AP
2005-02-18Labeling · Supplement 11 · standard — Letter ↗AP
2005-02-04Labeling · Supplement 10 · standard — Letter ↗AP
2005-01-31Efficacy · Supplement 9 · unknownAP
2003-12-23Manufacturing (CMC) · Supplement 8 · priority — Letter ↗AP
2003-03-20Labeling · Supplement 7 · standard — Letter ↗AP
2002-06-07Efficacy · Supplement 5 · priority — Letter ↗AP
2002-06-03Manufacturing (CMC) · Supplement 6 · priority — Review ↗AP
2000-08-11Labeling · Supplement 2 · standard — Review ↗AP
2000-03-07Manufacturing (CMC) · Supplement 1 · priority — Review ↗AP
2000-02-09Type 1 - New Molecular Entity · Original · priority — Medication Guide ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →