FDA.reportPublic FDA data

Application 019854

Type
NDA
Sponsor
MYLAN SPECIALITY LP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEPENPENICILLAMINETABLET;ORAL250MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0037-4401DepenPenicillamineMeda PharmaceuticalsNDACurrent
0037-4401DepenPenicillamineMeda PharmaceuticalsNDACurrent