LESCOL XL
Approved
Approval ID
0d466214-78a8-44cd-923c-c286a0f74f66
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 23, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
fluvastatin sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4601
Application NumberNDA021192
Product Classification
M
Marketing Category
C73594
G
Generic Name
fluvastatin sodium
Product Specifications
Route of AdministrationORAL
Effective DateMarch 23, 2011
FDA Product Classification
INGREDIENTS (10)
FLUVASTATIN SODIUMActive
Quantity: 80 mg in 1 1
Code: PYF7O1FV7F
Classification: ACTIB
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSE 2208 (15000 MPA.S)Inactive
Code: Z78RG6M2N2
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
POTASSIUM BICARBONATEInactive
Code: HM5Z15LEBN
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT