← FDA DRUG APPROVALS

FDA NDA · NDA208587

ENDARI

glutamine

Sponsor: EMMAUS MEDCL

APPLICATION
NDA208587
TYPE
NDA
ORIGINAL APPROVAL
2017-07-07
LATEST ACTION
2025-06-18
ROUTE
ORAL
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Prescription

Products

ENDARI · ReferencePrescription
L-GLUTAMINE 5GM/PACKET · FOR SOLUTION · ORAL

Approval history

2025-06-18Labeling · Supplement 4 · standard — Label ↗AP
2020-10-29Labeling · Supplement 3 · standard — Label ↗AP
2020-04-22Labeling · Supplement 2 · standard — Label ↗AP
2019-11-01Labeling · Supplement 1 · standard — Letter ↗AP
2017-07-07Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →