lovastatin
LOVASTATIN TABLETS USP
Approved
Approval ID
caf7c3af-8256-4557-af40-e8143e9af9f1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 19, 2012
Manufacturers
FDA
Mutual Pharmaceutical Company, Inc.
DUNS: 121735955
Products 3
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 Code53489-607
Application NumberANDA077520
Product Classification
M
Marketing Category
C73584
G
Generic Name
lovastatin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 19, 2012
FDA Product Classification
INGREDIENTS (6)
lovastatinActive
Quantity: 10 mg in 1 1
Code: 9LHU78OQFD
Classification: ACTIB
butylated hydroxyanisoleInactive
Code: REK4960K2U
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
lovastatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53489-608
Application NumberANDA077520
Product Classification
M
Marketing Category
C73584
G
Generic Name
lovastatin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 19, 2012
FDA Product Classification
INGREDIENTS (8)
lovastatinActive
Quantity: 20 mg in 1 1
Code: 9LHU78OQFD
Classification: ACTIB
butylated hydroxyanisoleInactive
Code: REK4960K2U
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
FD&C blue no. 2Inactive
Code: L06K8R7DQK
Classification: IACT
aluminum oxideInactive
Code: LMI26O6933
Classification: IACT
lovastatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53489-609
Application NumberANDA077520
Product Classification
M
Marketing Category
C73584
G
Generic Name
lovastatin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 19, 2012
FDA Product Classification
INGREDIENTS (6)
lovastatinActive
Quantity: 40 mg in 1 1
Code: 9LHU78OQFD
Classification: ACTIB
butylated hydroxyanisoleInactive
Code: REK4960K2U
Classification: IACT
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT