Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lovastatin
Product Details
NDC Product Code
53217-304Application Number
ANDA078296Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 25, 2017ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
LovastatinActive
Code: 9LHU78OQFDClass: ACTIBQuantity: 10 mg in 1 1
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2UClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT