ENALAPRIL MALEATE
These highlights do not include all the information needed to use ENALAPRIL MALEATE ORAL SOLUTION safely and effectively. See full prescribing information for ENALAPRIL MALEATE ORAL SOLUTION. ENALAPRIL MALEATE oral solution Initial U.S. Approval: 1985
Approved
Approval ID
337707cc-4ed9-4121-bfff-c5015e5eca9d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 18, 2024
Manufacturers
FDA
Aurobindo Pharma Limited
DUNS: 650082092
Products 1
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 Code59651-529
Application NumberANDA216458
Product Classification
M
Marketing Category
C73584
G
Generic Name
ENALAPRIL MALEATE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 18, 2024
FDA Product Classification
INGREDIENTS (8)
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
ENALAPRIL MALEATEActive
Quantity: 1 mg in 1 mL
Code: 9O25354EPJ
Classification: ACTIB
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT