FDA.reportPublic FDA data

Application 078556

Type
ANDA
Sponsor
IMPAX LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIGOXINDIGOXINTABLET;ORAL0.125MGNoNo
002DIGOXINDIGOXINTABLET;ORAL0.25MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-9811DigoxinDIGOXINAmneal Pharmaceuticals of New York LLCANDACurrent
0115-9811DigoxinDIGOXINAmneal Pharmaceuticals of New York LLCANDACurrent
0115-9811DigoxinDIGOXINImpax GenericsANDACurrent
0115-9811DigoxinDIGOXINAmneal Pharmaceuticals of New York LLCANDACurrent
0115-9822DigoxinDIGOXINAmneal Pharmaceuticals of New York LLCANDACurrent
0115-9822DigoxinDIGOXINAmneal Pharmaceuticals of New York LLCANDACurrent
0115-9822DigoxinDIGOXINAmneal Pharmaceuticals of New York LLCANDACurrent
0115-9822DigoxinDIGOXINImpax GenericsANDACurrent
53808-0699DigoxinDIGOXINState of Florida DOH Central PharmacyANDACurrent
68084-366DigoxinDIGOXINAmerican Health PackagingANDACurrent
68084-366DigoxinDIGOXINAmerican Health PackagingANDACurrent
68084-366DigoxinDIGOXINAmerican Health PackagingANDACurrent
68084-680DigoxinDIGOXINAmerican Health PackagingANDACurrent
68084-680DigoxinDIGOXINAmerican Health PackagingANDACurrent
68084-680DigoxinDIGOXINAmerican Health PackagingANDACurrent
71335-1052DigoxinDIGOXINBryant Ranch PrepackANDACurrent
71335-1052DigoxinDIGOXINBryant Ranch PrepackANDACurrent