FDA.reportPublic FDA data

Application 076546

Type
ANDA
Sponsor
LUPIN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRIMETHOBENZAMIDE HYDROCHLORIDETRIMETHOBENZAMIDE HYDROCHLORIDECAPSULE;ORAL300MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43386-660Trimethobenzamide HydrochlorideTrimethobenzamide HydrochlorideLupin Pharmaceuticals,Inc.ANDACurrent
43386-660Trimethobenzamide HydrochlorideTrimethobenzamide HydrochlorideLupin Pharmaceuticals,Inc.ANDACurrent
50090-2122Trimethobenzamide HydrochlorideTrimethobenzamide HydrochlorideA-S Medication SolutionsANDACurrent
61919-884TrimethobenzamideTrimethobenzamideDirect_RxANDACurrent
61919-884TrimethobenzamideTrimethobenzamideDirect_RxANDACurrent
70518-0510Trimethobenzamide HydrochlorideTrimethobenzamide HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0510Trimethobenzamide HydrochlorideTrimethobenzamide HydrochlorideREMEDYREPACK INC.ANDACurrent
71335-0800Trimethobenzamide HydrochlorideTrimethobenzamide HydrochlorideBryant Ranch PrepackANDACurrent
71335-0800Trimethobenzamide HydrochlorideTrimethobenzamide HydrochlorideBryant Ranch PrepackANDACurrent