FDA.reportPublic FDA data

Application 075788

Type
ANDA
Sponsor
TARO PHARM INDS

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
21695-780Enalapril Maleate and HydrochlorothiazideEnalapril Maleate and HydrochlorothiazideRebel Distributors CorpANDACurrent
51672-4045Enalapril Maleate and HydrochlorothiazideEnalapril Maleate and HydrochlorothiazideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4045Enalapril Maleate and HydrochlorothiazideEnalapril Maleate and HydrochlorothiazideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4046Enalapril Maleate and HydrochlorothiazideEnalapril Maleate and HydrochlorothiazideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4046Enalapril Maleate and HydrochlorothiazideEnalapril Maleate and HydrochlorothiazideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
68071-4144Enalapril Maleate and HydrochlorothiazideEnalapril Maleate and HydrochlorothiazideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4144Enalapril Maleate and HydrochlorothiazideEnalapril Maleate and HydrochlorothiazideNuCare Pharmaceuticals,Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8789ORIG2004-06-24
8790ORIG2004-06-03