Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Pliva Hrvatska d.o.o.
International Laboratories, LLC
499659316
Products3
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
54458-844Application Number
ANDA075551Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 18, 2019LovastatinActive
Code: 9LHU78OQFDClass: ACTIBQuantity: 40 mg in 1 1
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2UClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
LOVASTATIN
Product Details
NDC Product Code
54458-845Application Number
ANDA075551Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 18, 2019LovastatinActive
Code: 9LHU78OQFDClass: ACTIBQuantity: 20 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2UClass: IACT
LOVASTATIN
Product Details
NDC Product Code
54458-846Application Number
ANDA075551Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 18, 2019LovastatinActive
Code: 9LHU78OQFDClass: ACTIBQuantity: 10 mg in 1 1
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2UClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT