FDA.reportPublic FDA data

Application 076474

Type
ANDA
Sponsor
MYLAN INSTITUTIONAL

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-4699Esmolol Hydrochlorideesmolol hydrochlorideA-S Medication SolutionsANDACurrent
51662-1322ESMOLOL HYDROCHLORIDEESMOLOL HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1322ESMOLOL HYDROCHLORIDEESMOLOL HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1322ESMOLOL HYDROCHLORIDEESMOLOL HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1322ESMOLOL HYDROCHLORIDEESMOLOL HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstANDACurrent
52584-049Esmolol HydrochlorideEsmolol HydrochlorideGeneral Injectables and Vaccines, Inc.ANDACurrent
67457-182Esmolol Hydrochlorideesmolol hydrochlorideMylan Institutional LLCANDACurrent
67457-182Esmolol Hydrochlorideesmolol hydrochlorideMylan Institutional LLCANDACurrent