Lovastatin
LOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only
Approved
Approval ID
f208f4a4-cb3f-40bd-9873-bba0c8ae8bd4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 25, 2017
Manufacturers
FDA
Aidarex Pharmaceuticals LLC
DUNS: 801503249
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
lovastatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53217-304
Application NumberANDA078296
Product Classification
M
Marketing Category
C73584
G
Generic Name
lovastatin
Product Specifications
Route of AdministrationORAL
Effective DateMay 25, 2017
FDA Product Classification
INGREDIENTS (9)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
LOVASTATINActive
Quantity: 10 mg in 1 1
Code: 9LHU78OQFD
Classification: ACTIB
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT