ENALAPRIL MALEATE
Approved
Approval ID
dd7f12a7-7fe5-470b-b151-6ccf19945638
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 3, 2010
Manufacturers
FDA
State of Florida DOH Central Pharmacy
DUNS: 829348114
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ENALAPRIL MALEATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0243
Application NumberANDA075483
Product Classification
M
Marketing Category
C73584
G
Generic Name
ENALAPRIL MALEATE
Product Specifications
Route of AdministrationORAL
Effective DateAugust 3, 2010
FDA Product Classification
INGREDIENTS (1)
ENALAPRIL MALEATEActive
Quantity: 10 mg in 1 1
Code: 9O25354EPJ
Classification: ACTIM
ENALAPRIL MALEATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0242
Application NumberANDA075483
Product Classification
M
Marketing Category
C73584
G
Generic Name
ENALAPRIL MALEATE
Product Specifications
Route of AdministrationORAL
Effective DateAugust 3, 2010
FDA Product Classification
INGREDIENTS (1)
ENALAPRIL MALEATEActive
Quantity: 5 mg in 1 1
Code: 9O25354EPJ
Classification: ACTIM
ENALAPRIL MALEATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0244
Application NumberANDA075483
Product Classification
M
Marketing Category
C73584
G
Generic Name
ENALAPRIL MALEATE
Product Specifications
Route of AdministrationORAL
Effective DateAugust 3, 2010
FDA Product Classification
INGREDIENTS (2)
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
ENALAPRIL MALEATEActive
Quantity: 20 mg in 1 1
Code: 9O25354EPJ
Classification: ACTIM
ENALAPRIL MALEATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0966
Application NumberANDA075483
Product Classification
M
Marketing Category
C73584
G
Generic Name
ENALAPRIL MALEATE
Product Specifications
Route of AdministrationORAL
Effective DateAugust 3, 2010
FDA Product Classification
INGREDIENTS (1)
ENALAPRIL MALEATEActive
Quantity: 2.5 mg in 1 1
Code: 9O25354EPJ
Classification: ACTIM