← FDA DRUG APPROVALS

FDA NDA · NDA206940

VIBERZI

eluxadoline

Sponsor: ABBVIE

APPLICATION
NDA206940
TYPE
NDA
ORIGINAL APPROVAL
2015-05-27
LATEST ACTION
2020-06-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

VIBERZI · ReferencePrescription
ELUXADOLINE 100MG · TABLET · ORAL
VIBERZI · ReferencePrescription
ELUXADOLINE 75MG · TABLET · ORAL

Approval history

2020-06-17Labeling · Supplement 7 · standard — Label ↗AP
2018-06-26Labeling · Supplement 6 · standard — Label ↗AP
2018-04-13Labeling · Supplement 3 · standard — Label ↗AP
2017-11-08Labeling · Supplement 5 · standard — Letter ↗AP
2017-04-20Labeling · Supplement 2 · standard — Letter ↗AP
2017-02-02Labeling · Supplement 1 · standard — Label ↗AP
2015-05-27Type 1 - New Molecular Entity · Original · priority — Label ↗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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