NORLIQVA
These highlights do not include all the information needed to use NORLIQVA safely and effectively. See full prescribing information for NORLIQVA. NORLIQVA (amlodipine) oral solutionInitial U.S. Approval: 1992
Approved
Approval ID
c1730a51-4383-4c61-a9a1-7e1326bd0abe
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 28, 2022
Manufacturers
FDA
CMP Pharma, Inc.
DUNS: 005224175
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
amlodipine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code46287-035
Application NumberNDA214439
Product Classification
M
Marketing Category
C73594
G
Generic Name
amlodipine
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 28, 2022
FDA Product Classification
INGREDIENTS (5)
glycerinInactive
Code: PDC6A3C0OX
Classification: IACT
amlodipineActive
Quantity: 1 mg in 1 mL
Code: 1J444QC288
Classification: ACTIB
maltitolInactive
Code: D65DG142WK
Classification: IACT
alcoholInactive
Code: 3K9958V90M
Classification: IACT
butylated hydroxyanisoleInactive
Code: REK4960K2U
Classification: IACT