FDA.reportPublic FDA data

Application 206342

Type
ANDA
Sponsor
POLYGEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDETABLET;ORAL37.5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
52605-022Phentermine hydrochloridePhentermine hydrochloridePOLYGEN PHARMACEUTICALS INC.ANDACurrent
52605-022Phentermine hydrochloridePhentermine hydrochloridePOLYGEN PHARMACEUTICALS INC.ANDACurrent