FDA.reportPublic FDA data

Application 208538

Type
ANDA
Sponsor
GLAND PHARMA LTD

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
25021-314esmolol hydrochlorideesmolol hydrochlorideSagent PharmaceuticalsANDACurrent
68083-211Esmolol HydrochlorideEsmolol HydrochlorideGland Pharma LimitedANDACurrent
68083-211Esmolol HydrochlorideEsmolol HydrochlorideGland Pharma LimitedANDACurrent