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FDA NDA · NDA021775

ENTEREG

Sponsor: CUBIST PHARMS

APPLICATION
NDA021775
TYPE
NDA
ORIGINAL APPROVAL
2008-05-20
LATEST ACTION
2023-06-12
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

ENTEREG · ReferenceDiscontinued
ALVIMOPAN 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL

Approval history

2023-06-12REMS · Supplement 20 — Letter ↗AP
2020-11-17Labeling · Supplement 18 · standard — Letter ↗AP
2019-12-19REMS · Supplement 15 — Letter ↗AP
2019-10-10Labeling · Supplement 16 · standard — Letter ↗AP
2016-05-18REMS · Supplement 13 — Letter ↗AP
2014-05-29Manufacturing (CMC) · Supplement 12 · standardAP
2013-10-18Efficacy · Supplement 10 · standard — Letter ↗AP
2012-10-21Labeling · Supplement 8 · standard — Label ↗AP
2012-09-25REMS · Supplement 7 — Letter ↗AP
2009-11-06Labeling · Supplement 4 · standard — Label ↗AP
2009-02-05Labeling · Supplement 1 · standard — Letter ↗AP
2008-05-20Type 1 - New Molecular Entity · Original · standard — Summary Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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