FDA.reportPublic FDA data

Application 040747

Type
ANDA
Sponsor
TEDOR PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BENZPHETAMINE HYDROCHLORIDEBENZPHETAMINE HYDROCHLORIDETABLET;ORAL50MGNoNo
002BENZPHETAMINE HYDROCHLORIDEBENZPHETAMINE HYDROCHLORIDETABLET;ORAL25MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
12634-118Benzphetamine HydrochlorideBenzphetamine HydrochlorideApotheca Inc.ANDACurrent
53217-175Benzphetamine HydrochlorideBenzphetamine HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
71335-0768Benzphetamine HydrochlorideBenzphetamine HydrochlorideBryant Ranch PrepackANDACurrent
75834-100Benzphetamine HydrochlorideBenzphetamine HydrochlorideNivagen Pharmaceuticals, Inc.ANDACurrent
75834-102Benzphetamine HydrochlorideBenzphetamine HydrochlorideNivagen Pharmaceuticals, Inc.ANDACurrent