FDA.reportPublic FDA data

Application 040762

Type
ANDA
Sponsor
ELITE LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PHENDIMETRAZINE TARTRATEPHENDIMETRAZINE TARTRATETABLET;ORAL35MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
64850-440PHENDIMETRAZINE TARTRATEPhendimetrazine TartrateElite Laboratories, IncANDACurrent
68462-561PHENDIMETRAZINE TARTRATEPhendimetrazine TartrateGlenmark Pharmaceuticals Inc.,USAANDACurrent