PREXXARTAN
These highlights do not include all the information needed to use PREXXARTAN safely and effectively. See full prescribing information for PREXXARTAN. PREXXARTAN (valsartan) oral solutionInitial U.S. Approval: 1996
Approved
Approval ID
df73d781-65d8-4aaa-9b0f-de4341f639ec
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 2, 2018
Manufacturers
FDA
Medicure International Inc.
DUNS: 860240324
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PREXXARTAN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code25208-100
Application NumberNDA209139
Product Classification
M
Marketing Category
C73594
G
Generic Name
PREXXARTAN
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 2, 2018
FDA Product Classification
INGREDIENTS (8)
VALSARTANActive
Quantity: 4 mg in 1 mL
Code: 80M03YXJ7I
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT