FDA.reportPublic FDA data

Application 214352

Type
ANDA
Sponsor
RICONPHARMA LLC

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50742-239MEXILETINE HYDROCHLORIDEMexiletine hydrochlorideIngenus Pharmaceuticals, LLCANDACurrent
50742-239MEXILETINE HYDROCHLORIDEMexiletine hydrochlorideIngenus Pharmaceuticals, LLCANDACurrent
50742-240MEXILETINE HYDROCHLORIDEMexiletine hydrochlorideIngenus Pharmaceuticals, LLCANDACurrent
50742-240MEXILETINE HYDROCHLORIDEMexiletine hydrochlorideIngenus Pharmaceuticals, LLCANDACurrent
50742-241MEXILETINE HYDROCHLORIDEMexiletine hydrochlorideIngenus Pharmaceuticals, LLCANDACurrent
50742-241MEXILETINE HYDROCHLORIDEMexiletine hydrochlorideIngenus Pharmaceuticals, LLCANDACurrent