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FDA NDA · NDA208854

SYMPROIC

naldemedine

Sponsor: BDSI

APPLICATION
NDA208854
TYPE
NDA
ORIGINAL APPROVAL
2017-03-23
LATEST ACTION
2025-07-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

SYMPROIC · ReferencePrescription
NALDEMEDINE TOSYLATE EQ 0.2MG BASE · TABLET · ORAL

Approval history

2025-07-15Labeling · Supplement 7 · standard — Letter ↗AP
2018-01-24Labeling · Supplement 2 · standard — Label ↗AP
2017-08-01Labeling · Supplement 1 · standard — Label ↗AP
2017-03-23Type 1 - New Molecular Entity · Original · standard — Letter ↗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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