FDA.reportPublic FDA data

Application 205792

Type
ANDA
Sponsor
AJANTA PHARMA 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
27241-049EntacaponeEntacaponeAjanta Pharma LimitedANDACurrent
27241-049EntacaponeEntacaponeAjanta Pharma USA Inc.ANDACurrent
27241-049EntacaponeEntacaponeAjanta Pharma LimitedANDACurrent
27241-049EntacaponeEntacaponeAjanta Pharma LimitedANDACurrent
27241-049EntacaponeEntacaponeAjanta Pharma USA Inc.ANDACurrent