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FDA NDA · NDA022000

LIALDA

mesalamine

Sponsor: TAKEDA PHARMS USA

APPLICATION
NDA022000
TYPE
NDA
ORIGINAL APPROVAL
2007-01-16
LATEST ACTION
2023-10-24
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Prescription

Products

LIALDA · ReferencePrescription
MESALAMINE 1.2GM · TABLET, DELAYED RELEASE · ORAL

Approval history

2023-10-24Labeling · Supplement 27 · standard — Label ↗AP
2022-11-16Labeling · Supplement 25 · standard — Letter ↗AP
2021-11-01Labeling · Supplement 23 · standard — Letter ↗AP
2021-05-25Labeling · Supplement 22 · standard — Letter ↗AP
2020-12-17Labeling · Supplement 21 · standard — Label ↗AP
2020-10-01Labeling · Supplement 20 · standard — Letter ↗AP
2020-06-26Efficacy · Supplement 19 · standard — Letter ↗AP
2019-07-18Labeling · Supplement 18 · standard — Label ↗AP
2018-05-23Labeling · Supplement 17 · standard — Letter ↗AP
2017-08-22Labeling · Supplement 15 · standard — Label ↗AP
2017-07-27Labeling · Supplement 16 · standard — Letter ↗AP
2014-10-16Labeling · Supplement 13 · standard — Label ↗AP
2014-03-14Labeling · Supplement 12 · standardAP
2013-12-16Labeling · Supplement 11 · standard — Label ↗AP
2013-08-28Labeling · Supplement 9 · standard — Letter ↗AP
2013-08-09Labeling · Supplement 10 · standard — Letter ↗AP
2013-08-09Labeling · Supplement 8 · standard — Label ↗AP
2011-07-14Efficacy · Supplement 5 · standard — Label ↗AP
2010-09-22Labeling · Supplement 3 · standard — Label ↗AP
2009-10-30Labeling · Supplement 2 · standard — Label ↗AP
2007-01-16Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

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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.

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