Enalapril Oral Solution

Brand(s)
Epaned
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Silvergate Pharmaceuticals, Inc. (2015-01-12)
Oldest Current Product
2013-08-22
License(s)
NDA
RxNORM
ORAL SOLUTION\ENALAPRIL
FDAOB
ORAL\FOR SOLUTION\ENALAPRIL MALEATE
SPL Active
ORAL\POWDER, FOR SOLUTION\ENALAPRIL MALEATE
SPL Moiety
ORAL\POWDER, FOR SOLUTION\ENALAPRILAT ANHYDROUS

product(s) by strength(s)

enalapril maleate 1 mg/ml oral solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1526521001EpanedNDASilvergate Pharmaceuticals, Inc.2013-08-22ENALAPRIL MALEATEORALPOWDER, FOR SOLUTIONNDA20430894c9a9d6-957f-4667-8f09-509e99bac777

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA204308EPANED KITSILVERGATE PHARMACEUTICALS INC2013-08-13p8778366, METHOD OF TREATING HYPERTENSION/ TREATMENT OF HYPERTENSION
p8568747, SUBSTANCE
NDA204308_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA204308_001RXENALAPRIL MALEATE (1MG/ML)ORALFOR SOLUTIONTrue2013-08-13EPANED KIT

patent(s)

#idexpiration dateapplication(s)
1p8568747 (view patent)2032-11-06NDA204308
2p8778366 (view patent)2032-11-06NDA204308

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
194c9a9d6-957f-4667-8f09-509e99bac777 (view SPL)These highlights do not include all the information needed to use EPANED safely and effectively. See full prescribing information for EPANED. EPANED (enalapril) for Oral SolutionInitial U.S. Approval: 1985prescriptionHuman PrescriptionSilvergate Pharmaceuticals, Inc.ANALYSIS, API MANUFACTURE, MANUFACTURE2015-01-123526521001

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII