FDA.reportPublic FDA data

Application 086809

Type
ANDA
Sponsor
CHARTWELL RX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SPIRONOLACTONESPIRONOLACTONETABLET;ORAL25MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-1599SpironolactoneSpironolactoneSandoz IncANDACurrent
0781-1599SpironolactoneSpironolactoneSandoz IncANDACurrent