ATORVALIQ
These highlights do not include all the information needed to use ATORVALIQ safely and effectively. See full prescribing information for ATORVALIQ. ATORVALIQ (atorvastatin calcium) oral suspensionInitial U.S. Approval: 1996
Approved
Approval ID
41fca2d8-7f3f-45b9-8974-81b89accc211
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 16, 2023
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.
ATORVALIQ
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code46287-030
Application NumberNDA213260
Product Classification
M
Marketing Category
C73594
G
Generic Name
ATORVALIQ
Product Specifications
Route of AdministrationORAL
Effective DateAugust 8, 2017
FDA Product Classification
INGREDIENTS (9)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMInactive
Code: K679OBS311
Classification: IACT
MAGNESIUM ALUMINUM SILICATEInactive
Code: 6M3P64V0NC
Classification: IACT
ETHYLPARABENInactive
Code: 14255EXE39
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ATORVASTATIN CALCIUM TRIHYDRATEActive
Quantity: 20 mg in 5 mL
Code: 48A5M73Z4Q
Classification: ACTIM