FDA.reportPublic FDA data

Application 078941

Type
ANDA
Sponsor
WOCKHARDT LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ENTACAPONEENTACAPONETABLET;ORAL200MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55648-711EntacaponeEntacaponeWockhardt LimitedANDACurrent
64679-711EntacaponeEntacaponeWockhardt USA LLC.ANDACurrent
64679-711EntacaponeEntacaponeWockhardt USA LLC.ANDACurrent
64679-711EntacaponeEntacaponeWockhardt USA LLC.ANDACurrent
64679-711EntacaponeEntacaponeWockhardt USA LLC.ANDACurrent