Nutrestore

NDA 21667, held by Emmaus Medcl. L-Glutamine.

As of Nov 14, 2026, NDA 21667 (Nutrestore), held by Emmaus Medcl, was first approved by FDA on Jun 10, 2004, with 3 approved supplements and 0 published complete response letters.

First approved: Jun 10, 2004
Review: Standard
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Jun 10, 2004	Original applicationNew molecular entity · Standard review	Approved	Label Review

Products

1 strengths and forms

Product	Active ingredient	Marketing
Nutrestore5GM/PACKET · for solution;oral	L-Glutamine	DiscontinuedReference drug

All 4 submissions, including labeling and manufacturing supplements


Mar 31, 2021	Supplement 7Labeling · Standard review	Approved	Letter Label
Oct 30, 2014	Supplement 5Manufacturing · Standard review	Approved	None posted
Mar 14, 2011	Supplement 3Labeling	Approved	Label Letter
Jun 10, 2004	Original applicationNew molecular entity · Standard review	Approved	Label Review

Identifiers

Application: NDA 21667
Drugs@FDA: Overview at FDA
Company: Emmaus Medical

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters