Endari
These highlights do not include all the information needed to use ENDARI™ safely and effectively. See full prescribing information for ENDARI. ENDARI (L-glutamine oral powder ) Initial U.S. Approval: 2017
Approved
Approval ID
d5a783f4-12ef-4326-8faa-40018e45ba3b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 19, 2022
Manufacturers
FDA
Emmaus Medical, Inc.
DUNS: 784073434
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Glutamine
PRODUCT DETAILS
NDC Product Code42457-420
Application NumberNDA208587
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateOctober 27, 2020
Generic NameGlutamine
INGREDIENTS (1)
GlutamineActive
Quantity: 5 g in 1 1
Code: 0RH81L854J
Classification: ACTIB