FDA.reportPublic FDA data

Application 074377

Type
ANDA
Sponsor
TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MEXILETINE HYDROCHLORIDEMEXILETINE HYDROCHLORIDECAPSULE;ORAL150MGNoNo
002MEXILETINE HYDROCHLORIDEMEXILETINE HYDROCHLORIDECAPSULE;ORAL200MGNoNo
003MEXILETINE HYDROCHLORIDEMEXILETINE HYDROCHLORIDECAPSULE;ORAL250MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-8739Mexiletine HydrochlorideMexiletine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8739Mexiletine HydrochlorideMexiletine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8740Mexiletine HydrochlorideMexiletine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8740Mexiletine HydrochlorideMexiletine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8741Mexiletine HydrochlorideMexiletine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-8741Mexiletine HydrochlorideMexiletine HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
42291-624Mexiletine HydrochlorideMexiletine HydrochlorideAvKARE, Inc.ANDACurrent
42291-624Mexiletine HydrochlorideMexiletine HydrochlorideAvKAREANDACurrent
42291-625Mexiletine HydrochlorideMexiletine HydrochlorideAvKARE, Inc.ANDACurrent
42291-625Mexiletine HydrochlorideMexiletine HydrochlorideAvKAREANDACurrent
42291-626Mexiletine HydrochlorideMexiletine HydrochlorideAvKARE, Inc.ANDACurrent
42291-626Mexiletine HydrochlorideMexiletine HydrochlorideAvKAREANDACurrent
68151-2347Mexiletine HydrochlorideMexiletine HydrochlorideCarilion Materials ManagementANDACurrent
68151-2985Mexiletine HydrochlorideMexiletine HydrochlorideCarilion Materials ManagementANDACurrent
68151-2986Mexiletine HydrochlorideMexiletine HydrochlorideCarilion Materials ManagementANDACurrent