FDA.reportPublic FDA data

Application 202354

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ETOMIDATEETOMIDATEINJECTABLE;INJECTION2MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9310EtomidateEtomidateWest-Ward Pharmaceuticals CorpANDACurrent
0143-9310EtomidateEtomidateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9311EtomidateEtomidateWest-Ward Pharmaceuticals CorpANDACurrent
0143-9311EtomidateEtomidateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9506EtomidateEtomidateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9506EtomidateEtomidateWest-Ward Pharmaceuticals CorpANDACurrent
0143-9507EtomidateEtomidateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9507EtomidateEtomidateWest-Ward Pharmaceuticals CorpANDACurrent
51662-1485ETOMIDATEETOMIDATEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1485ETOMIDATEETOMIDATEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
72572-160EtomidateEtomidateCivica, Inc.ANDACurrent
72572-161EtomidateEtomidateCivica, Inc.ANDACurrent