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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42457-420
Application NumberNDA208587
Product Classification
M
Marketing Category
C73594
G
Generic Name
Glutamine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 27, 2020
FDA Product Classification
INGREDIENTS (1)
GlutamineActive
Quantity: 5 g in 1 1
Code: 0RH81L854J
Classification: ACTIB