FDA.reportPublic FDA data

Application 076573

Type
ANDA
Sponsor
FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ESMOLOL HYDROCHLORIDEESMOLOL HYDROCHLORIDEINJECTABLE;INJECTION10MG/MLNoNo
002ESMOLOL HYDROCHLORIDEESMOLOL HYDROCHLORIDEINJECTABLE;INJECTION20MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51662-1371ESMOLOL HYDROCHLORIDEESMOLOL HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1371ESMOLOL HYDROCHLORIDEESMOLOL HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1371ESMOLOL HYDROCHLORIDEESMOLOL HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
63323-652Esmolol HydrochlorideESMOLOL HYDROCHLORIDEFresenius Kabi USA, LLCANDACurrent
63323-652Esmolol HydrochlorideESMOLOL HYDROCHLORIDEFresenius Kabi USA, LLCANDACurrent