FDA.reportPublic FDA data

Application 213500

Type
ANDA
Sponsor
CROSSMEDIKA SA

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
0527-4107Mexiletine HydrochlorideMexiletine HydrochlorideLannett Company, Inc.ANDACurrent
0527-4107Mexiletine HydrochlorideMexiletine HydrochlorideLannett Company, Inc.ANDACurrent
0527-4107Mexiletine HydrochlorideMexiletine HydrochlorideLannett Company, Inc.ANDACurrent
0527-4108Mexiletine HydrochlorideMexiletine HydrochlorideLannett Company, Inc.ANDACurrent
0527-4108Mexiletine HydrochlorideMexiletine HydrochlorideLannett Company, Inc.ANDACurrent
0527-4108Mexiletine HydrochlorideMexiletine HydrochlorideLannett Company, Inc.ANDACurrent
0527-4109Mexiletine HydrochlorideMexiletine HydrochlorideLannett Company, Inc.ANDACurrent
0527-4109Mexiletine HydrochlorideMexiletine HydrochlorideLannett Company, Inc.ANDACurrent
0527-4109Mexiletine HydrochlorideMexiletine HydrochlorideLannett Company, Inc.ANDACurrent
10135-730Mexiletine HydrochlorideMexiletine HydrochlorideMarlex Pharmaceuticals, Inc.ANDACurrent
10135-731Mexiletine HydrochlorideMexiletine HydrochlorideMarlex Pharmaceuticals, Inc.ANDACurrent
10135-732Mexiletine HydrochlorideMexiletine HydrochlorideMarlex Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
64389ORIG2020-08-24