Application 075496

Type
ANDA
Sponsor
SANDOZ INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ENALAPRIL MALEATEENALAPRIL MALEATETABLET;ORAL2.5MGNoNo
002ENALAPRIL MALEATEENALAPRIL MALEATETABLET;ORAL5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-442Enalapril Maleateenalapril maleateNorthstar RxLLCANDACurrent
16714-443Enalapril Maleateenalapril maleateNorthstar RxLLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8693ORIG2004-06-03