FDA.reportPublic FDA data

Application 204679

Type
ANDA
Sponsor
WEST WARD PHARM CORP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ROCURONIUM BROMIDEROCURONIUM BROMIDEINJECTABLE;INJECTION50MG/5ML (10MG/ML)NoNo
002ROCURONIUM BROMIDEROCURONIUM BROMIDEINJECTABLE;INJECTION100MG/10ML (10MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9250Rocuronium BromideRocuronium BromideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9250Rocuronium BromideRocuronium BromideWest-Ward PharmaceuticalsANDACurrent
0143-9250Rocuronium BromideRocuronium BromideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9251Rocuronium BromideRocuronium BromideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9251Rocuronium BromideRocuronium BromideWest-Ward PharmaceuticalsANDACurrent
0143-9251Rocuronium BromideRocuronium BromideHikma Pharmaceuticals USA Inc.ANDACurrent
72572-650Rocuronium BromideRocuronium BromideCivica, Inc.ANDACurrent
72572-650Rocuronium BromideRocuronium BromideCivica, Inc.ANDACurrent
72572-651Rocuronium BromideRocuronium BromideCivica, Inc.ANDACurrent
72572-651Rocuronium BromideRocuronium BromideCivica, Inc.ANDACurrent