FDA.reportPublic FDA data

Application 075727

Type
ANDA
Sponsor
ACP NIMBLE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDEENALAPRIL MALEATE; HYDROCHLOROTHIAZIDETABLET;ORAL5MG;12.5MGNoNo
002ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDEENALAPRIL MALEATE; HYDROCHLOROTHIAZIDETABLET;ORAL10MG;25MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0713-1044Enalapril Maleate and HydrochlorothiazideEnalapril Maleate and HydrochlorothiazideCosette Pharmaceuticals, Inc.ANDACurrent
0713-1044Enalapril Maleate and HydrochlorothiazideEnalapril Maleate and HydrochlorothiazideCosette Pharmaceuticals, Inc.ANDACurrent
0713-1044Enalapril Maleate and HydrochlorothiazideEnalapril Maleate and HydrochlorothiazideCosette Pharmaceuticals, Inc.ANDACurrent
0713-1044Enalapril Maleate and HydrochlorothiazideEnalapril Maleate and HydrochlorothiazideG&W Laboratories, Inc.ANDACurrent
0713-1052Enalapril Maleate and HydrochlorothiazideEnalapril Maleate and HydrochlorothiazideCosette Pharmaceuticals, Inc.ANDACurrent
0713-1052Enalapril Maleate and HydrochlorothiazideEnalapril Maleate and HydrochlorothiazideCosette Pharmaceuticals, Inc.ANDACurrent
0713-1052Enalapril Maleate and HydrochlorothiazideEnalapril Maleate and HydrochlorothiazideCosette Pharmaceuticals, Inc.ANDACurrent
0713-1052Enalapril Maleate and HydrochlorothiazideEnalapril Maleate and HydrochlorothiazideG&W Laboratories, Inc.ANDACurrent
71335-0870Enalapril Maleate and HydrochlorothiazideEnalapril Maleate and HydrochlorothiazideBryant Ranch PrepackANDACurrent
71335-0870Enalapril Maleate and HydrochlorothiazideEnalapril Maleate and HydrochlorothiazideBryant Ranch PrepackANDACurrent
71335-0870Enalapril Maleate and HydrochlorothiazideEnalapril Maleate and HydrochlorothiazideBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31000ORIG2004-06-24
8777ORIG2004-06-03