FDA.reportPublic FDA data

Application 216250

Type
ANDA
Sponsor
NOVITIUM PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDESOLUTION;TOPICAL4%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10135-736Lidocaine HydrochlorideLidocaine HydrochlorideMarlex Pharmaceuticals, Inc.ANDACurrent
70954-518Lidocaine HydrochlorideLidocaine HydrochlorideNovitium Pharma LLCANDACurrent