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FDA NDA · NDA208745

TRULANCE IMMEDIATE RELEASE

plecanatide

Sponsor: SALIX

APPLICATION
NDA208745
TYPE
NDA
ORIGINAL APPROVAL
2017-01-19
LATEST ACTION
2021-04-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

TRULANCE · ReferencePrescription
PLECANATIDE 3MG · TABLET · ORAL

Approval history

2021-04-13Labeling · Supplement 11 · standard — Letter ↗AP
2021-02-10Labeling · Supplement 7 · standard — Letter ↗AP
2020-10-29Labeling · Supplement 10 · standard — Letter ↗AP
2018-07-25Labeling · Supplement 2 · standard — Letter ↗AP
2018-01-24Efficacy · Supplement 1 · standard — Label ↗AP
2017-01-19Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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