FDA.reportPublic FDA data

Application 018243

Type
NDA
Sponsor
WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXYTOCINOXYTOCININJECTABLE;INJECTION10USP UNITS/ML (10USP UNITS/ML)YesYes
002OXYTOCINOXYTOCININJECTABLE;INJECTION100USP UNITS/10ML (10USP UNITS/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0641-6114OxytocinOxytocinHikma Pharmaceuticals USA Inc.NDACurrent
0641-6114OxytocinOxytocinWest-Ward Pharmaceutical Corp.NDACurrent
0641-6115OxytocinOxytocinHikma Pharmaceuticals USA Inc.NDACurrent
0641-6115OxytocinOxytocinWest-Ward Pharmaceutical Corp.NDACurrent