FloLipid
These highlights do not include all the information needed to use FLOLIPID safely and effectively. See full prescribing information for FLOLIPID. FLOLIPID (simvastatin) oral suspension Initial U.S. Approval: 1991
Approved
Approval ID
6ee17d10-6eb1-452a-99e8-02381368b3fe
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 9, 2023
Manufacturers
FDA
Salerno Pharmaceuticals Co.
DUNS: 963714766
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Simvastatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code29273-402
Application NumberNDA206679
Product Classification
M
Marketing Category
C73594
G
Generic Name
Simvastatin
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 9, 2023
FDA Product Classification
INGREDIENTS (13)
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMInactive
Code: K679OBS311
Classification: IACT
ETHYLPARABENInactive
Code: 14255EXE39
Classification: IACT
MAGNESIUM ALUMINUM SILICATEInactive
Code: 6M3P64V0NC
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SIMVASTATINActive
Quantity: 40 mg in 5 mL
Code: AGG2FN16EV
Classification: ACTIB
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT
Simvastatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code29273-401
Application NumberNDA206679
Product Classification
M
Marketing Category
C73594
G
Generic Name
Simvastatin
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 9, 2023
FDA Product Classification
INGREDIENTS (13)
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMInactive
Code: K679OBS311
Classification: IACT
SIMVASTATINActive
Quantity: 20 mg in 5 mL
Code: AGG2FN16EV
Classification: ACTIB
ACESULFAME POTASSIUMInactive
Code: 23OV73Q5G9
Classification: IACT
ETHYLPARABENInactive
Code: 14255EXE39
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
MAGNESIUM ALUMINUM SILICATEInactive
Code: 6M3P64V0NC
Classification: IACT