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FDA NDA · NDA021667

NUTRESTORE

Sponsor: EMMAUS MEDCL

APPLICATION
NDA021667
TYPE
NDA
ORIGINAL APPROVAL
2004-06-10
LATEST ACTION
2021-03-31
ROUTE
ORAL
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Discontinued

Products

NUTRESTORE · ReferenceDiscontinued
L-GLUTAMINE 5GM/PACKET · FOR SOLUTION · ORAL

Approval history

2021-03-31Labeling · Supplement 7 · standard — Letter ↗AP
2014-10-30Manufacturing (CMC) · Supplement 5 · standardAP
2011-03-14Labeling · Supplement 3 · unknown — Label ↗AP
2004-06-10Type 1 - New Molecular Entity · Original · standard — 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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