FDA.reportPublic FDA data

Application 074450

Type
ANDA
Sponsor
ANI PHARMS INC

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
51407-379Mexiletine HydrochlorideMexiletine HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-380Mexiletine HydrochlorideMexiletine HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
51407-381Mexiletine HydrochlorideMexiletine HydrochlorideGolden State Medical Supply, Inc.ANDACurrent
62559-820Mexiletine HydrochlorideMexiletine HydrochlorideANI Pharmaceuticals, Inc.ANDACurrent
62559-821Mexiletine HydrochlorideMexiletine HydrochlorideANI Pharmaceuticals, Inc.ANDACurrent
62559-822Mexiletine HydrochlorideMexiletine HydrochlorideANI Pharmaceuticals, Inc.ANDACurrent
63629-1962Mexiletine HydrochlorideMexiletine HydrochlorideBryant Ranch PrepackANDACurrent
63629-1963Mexiletine HydrochlorideMexiletine HydrochlorideBryant Ranch PrepackANDACurrent
63629-1963Mexiletine HydrochlorideMexiletine HydrochlorideBryant Ranch PrepackANDACurrent
63629-1964Mexiletine HydrochlorideMexiletine HydrochlorideBryant Ranch PrepackANDACurrent
63629-1964Mexiletine HydrochlorideMexiletine HydrochlorideBryant Ranch PrepackANDACurrent
63629-2145Mexiletine HydrochlorideMexiletine HydrochlorideBryant Ranch PrepackANDACurrent
63629-2145Mexiletine HydrochlorideMexiletine HydrochlorideBryant Ranch PrepackANDACurrent
63629-9290Mexiletine HydrochlorideMexiletine HydrochlorideBryant Ranch PrepackANDACurrent