FDA.reportPublic FDA data

Application 091120

Type
ANDA
Sponsor
HIKMA FARMACEUTICA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TESTOSTERONE ENANTHATETESTOSTERONE ENANTHATEINJECTABLE;INJECTION200MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9750TESTOSTERONE ENANTHATETESTOSTERONE ENANTHATEHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9750TESTOSTERONE ENANTHATETESTOSTERONE ENANTHATEWest-Ward Pharmaceuticals CorpANDACurrent