FDA.reportPublic FDA data

Application 214089

Type
ANDA
Sponsor
HAVIX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MEXILETINE HYDROCHLORIDEMEXILETINE HYDROCHLORIDECAPSULE;ORAL150MGNoNo
002MEXILETINE HYDROCHLORIDEMEXILETINE HYDROCHLORIDECAPSULE;ORAL200MGNoNo
003MEXILETINE HYDROCHLORIDEMEXILETINE HYDROCHLORIDECAPSULE;ORAL250MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62756-955MEXILETINE HYDROCHLORIDEmexiletine hydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
62756-956MEXILETINE HYDROCHLORIDEmexiletine hydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
62756-957MEXILETINE HYDROCHLORIDEmexiletine hydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
63629-9179MEXILETINE HYDROCHLORIDEmexiletine hydrochlorideBryant Ranch PrepackANDACurrent
63629-9179MEXILETINE HYDROCHLORIDEmexiletine hydrochlorideBryant Ranch PrepackANDACurrent
63629-9180MEXILETINE HYDROCHLORIDEmexiletine hydrochlorideBryant Ranch PrepackANDACurrent
63629-9180MEXILETINE HYDROCHLORIDEmexiletine hydrochlorideBryant Ranch PrepackANDACurrent
63629-9181MEXILETINE HYDROCHLORIDEmexiletine hydrochlorideBryant Ranch PrepackANDACurrent
63629-9181MEXILETINE HYDROCHLORIDEmexiletine hydrochlorideBryant Ranch PrepackANDACurrent
82012-028MEXILETINE HYDROCHLORIDEmexiletine hydrochlorideSenores Pharmaceuticals, Inc.ANDACurrent
82012-029MEXILETINE HYDROCHLORIDEmexiletine hydrochlorideSenores Pharmaceuticals, Inc.ANDACurrent