FDA.reportPublic FDA data

Application 076570

Type
ANDA
Sponsor
SUN PHARM INDUSTRIES

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
21695-448Trimethobenzamide HydrochlorideTrimethobenzamideRebel Distributors Corp.ANDACurrent
53489-376Trimethobenzamide HydrochlorideTrimethobenzamide HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
63629-3685Trimethobenzamide HydrochlorideTrimethobenzamide HydrochlorideBryant Ranch PrepackANDACurrent