Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Carilion Materials Management
079239644
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Carilion Materials Management
Carilion Materials Management
Carilion Materials Management
079239644
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lescol XL
Product Details
NDC Product Code
68151-4471Application Number
NDA021192Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
March 1, 2012HYPROMELLOSE 2208 (15000 MPA.S)Inactive
Code: Z78RG6M2N2Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FluvastatinActive
Code: PYF7O1FV7FClass: ACTIMQuantity: 80 mg in 1 1
HYDROXYPROPYL CELLULOSE (TYPE H)Inactive
Code: RFW2ET671PClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3BClass: IACT
POTASSIUM BICARBONATEInactive
Code: HM5Z15LEBNClass: IACT
POVIDONESInactive
Code: FZ989GH94EClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT