Application 075459

Type
ANDA
Sponsor
SANDOZ INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ENALAPRIL MALEATEENALAPRIL MALEATETABLET;ORAL10MGNoNo
002ENALAPRIL MALEATEENALAPRIL MALEATETABLET;ORAL20MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-444Enalapril Maleateenalapril maleateNorthstar RxLLCANDACurrent
16714-445Enalapril Maleateenalapril maleateNorthstar RxLLCANDACurrent
50090-5976Enalapril Maleateenalapril maleateA-S Medication SolutionsANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
30892ORIG2000-08-22