Active substance
L glutamine
- US FDA 5
- Safety 2
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| ENDARI | 5GM/PACKET | for solution · oral | EMMAUS MEDCL | Prescription | 7 Jul 2017 |
| L-GLUTAMINE | 5GM/PACKET | for solution · oral | NOVITIUM PHARMA | Prescription | 8 Jul 2024 |
| L-GLUTAMINE | 5GM/PACKET | for solution · oral | RENOVA PHARMS | Prescription | 14 May 2026 |
| L-GLUTAMINE | 5GM/PACKET | for solution · oral | ANNORA PHARMA | Prescription | 26 May 2026 |
| NUTRESTORE | 5GM/PACKET | for solution · oral | EMMAUS MEDCL | Discontinued | 10 Jun 2004 |
Safety signals and safety-related labeling changes
- US FDA 31 Mar 2021 NUTRESTORE — safety-related labeling change
Labeling sections changed: Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 22 Apr 2020 ENDARI — safety-related labeling change
Labeling sections changed: Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.