FDA.reportPublic FDA data

Application 078400

Type
ANDA
Sponsor
HIKMA FARMACEUTICA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUTORPHANOL TARTRATEBUTORPHANOL TARTRATEINJECTABLE;INJECTION1MG/MLNoNo
002BUTORPHANOL TARTRATEBUTORPHANOL TARTRATEINJECTABLE;INJECTION2MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9864Butorphanol TartrateButorphanol TartrateWest-Ward Pharmaceuticals CorpANDACurrent
0143-9864Butorphanol TartrateButorphanol TartrateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9867Butorphanol TartrateButorphanol TartrateWest-Ward Pharmaceuticals CorpANDACurrent
0143-9867Butorphanol TartrateButorphanol TartrateHikma Pharmaceuticals USA Inc.ANDACurrent