← FDA DRUG APPROVALS

FDA NDA · NDA202811

LINZESS

linaclotide

Sponsor: ABBVIE

APPLICATION
NDA202811
TYPE
NDA
ORIGINAL APPROVAL
2012-08-30
LATEST ACTION
2026-05-21
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

LINZESS · ReferencePrescription
LINACLOTIDE 72MCG · CAPSULE · ORAL
LINZESS · ReferencePrescription
LINACLOTIDE 145MCG · CAPSULE · ORAL
LINZESS · ReferencePrescription
LINACLOTIDE 290MCG · CAPSULE · ORAL

Approval history

2026-05-21Efficacy · Supplement 23 · priority — Label ↗AP
2025-11-04Efficacy · Supplement 22 · priority — Label ↗AP
2023-06-12Efficacy · Supplement 21 · priority — Letter ↗AP
2021-08-24Labeling · Supplement 18 · standard — Letter ↗AP
2021-04-12Labeling · Supplement 17 · standard — Letter ↗AP
2020-09-22Efficacy · Supplement 16 · standard — Letter ↗AP
2017-03-08Labeling · Supplement 13 · standard — Label ↗AP
2017-01-25Efficacy · Supplement 10 · standard — Label ↗AP
2017-01-06Manufacturing (CMC) · Supplement 12 · standardAP
2016-08-31Labeling · Supplement 11 · standard — Letter ↗AP
2016-05-18Manufacturing (CMC) · Supplement 8 · standardAP
2016-04-06Labeling · Supplement 7 · standard — Label ↗AP
2015-11-23Labeling · Supplement 9 · standard — Label ↗AP
2015-01-05Manufacturing (CMC) · Supplement 6 · standardAP
2014-12-11Manufacturing (CMC) · Supplement 1 · standardAP
2014-07-09Labeling · Supplement 4 · standard — Label ↗AP
2014-07-01Manufacturing (CMC) · Supplement 5 · standardAP
2013-11-08Manufacturing (CMC) · Supplement 2 · standardAP
2013-08-08Labeling · Supplement 3 · standard — Label ↗AP
2012-08-30Type 1 - New Molecular Entity · 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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