Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Physicians Total Care, Inc.
Physicians Total Care, Inc.
194123980
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
54868-4593Application Number
ANDA078296Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
March 28, 2011FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
LovastatinActive
Code: 9LHU78OQFDClass: ACTIBQuantity: 10 mg in 1 1
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
LOVASTATIN
Product Details
NDC Product Code
54868-4774Application Number
ANDA078296Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
March 28, 2011CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
LovastatinActive
Code: 9LHU78OQFDClass: ACTIBQuantity: 40 mg in 1 1
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2UClass: IACT
LOVASTATIN
Product Details
NDC Product Code
54868-4585Application Number
ANDA078296Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
March 28, 2011LovastatinActive
Code: 9LHU78OQFDClass: ACTIBQuantity: 20 mg in 1 1
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5XClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2UClass: IACT