JYLAMVO
These highlights do not include all the information needed to use JYLAMVO safely and effectively. See full prescribing information for JYLAMVO. JYLAMVO (methotrexate) oral solutionInitial U.S. Approval: 1953
Approved
Approval ID
96e931f5-51ae-4bdf-a441-bb0dd26d4c0e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 1, 2023
Manufacturers
FDA
SHORLA ONCOLOGY INC.
DUNS: 118055608
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Methotrexate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code81927-204
Application NumberNDA212479
Product Classification
M
Marketing Category
C73594
G
Generic Name
Methotrexate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 1, 2023
FDA Product Classification
INGREDIENTS (9)
METHOTREXATEActive
Quantity: 2 mg in 1 mL
Code: YL5FZ2Y5U1
Classification: ACTIB
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
ETHYLPARABENInactive
Code: 14255EXE39
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
METHYLPARABEN SODIUMInactive
Code: CR6K9C2NHK
Classification: IACT