← FDA DRUG APPROVALS

FDA NDA · NDA021830

ASACOL HD

Sponsor: ABBVIE

APPLICATION
NDA021830
TYPE
NDA
ORIGINAL APPROVAL
2008-05-29
LATEST ACTION
2022-11-16
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Discontinued

Products

ASACOL HD · ReferenceDiscontinued
MESALAMINE 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, DELAYED RELEASE · ORAL

Approval history

2022-11-16Labeling · Supplement 20 · standard — Letter ↗AP
2021-11-01Labeling · Supplement 19 · standard — Letter ↗AP
2020-10-01Labeling · Supplement 16 · standard — Letter ↗AP
2020-05-21Manufacturing (CMC) · Supplement 15 · standard — Label ↗AP
2018-04-18Labeling · Supplement 12 · standard — Label ↗AP
2017-07-27Labeling · Supplement 11 · standard — Letter ↗AP
2016-05-05Labeling · Supplement 10 · standard — Letter ↗AP
2015-10-22Manufacturing (CMC) · Supplement 9 · standardAP
2014-01-13Manufacturing (CMC) · Supplement 7 · standardAP
2013-10-18Efficacy · Supplement 6 · standard — Label ↗AP
2010-05-24Labeling · Supplement 5 · unknown — Label ↗AP
2009-04-23Labeling · Supplement 2 · standard — Letter ↗AP
2008-05-29Type 3 - New Dosage Form · Original · standard — Label ↗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 →