FDA.reportPublic FDA data

Application 210017

Type
ANDA
Sponsor
JUBILANT CADISTA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DROSPIRENONE AND ETHINYL ESTRADIOLDROSPIRENONE; ETHINYL ESTRADIOLTABLET;ORAL-283MG;0.03MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59746-764Drospirenone and Ethinyl EstradiolDrospirenone and ethinyl estradiolJubilant Cadista Pharmaceuticals IncANDACurrent
59746-764Drospirenone and Ethinyl EstradiolDrospirenone and ethinyl estradiolJubilant Cadista Pharmaceuticals IncANDACurrent