FDA.reportPublic FDA data

Application 211204

Type
ANDA
Sponsor
AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ERYTHROMYCIN ETHYLSUCCINATEERYTHROMYCIN ETHYLSUCCINATEGRANULE;ORALEQ 200MG BASE/5MLNoNo
002ERYTHROMYCIN ETHYLSUCCINATEERYTHROMYCIN ETHYLSUCCINATEGRANULE;ORALEQ 400MG BASE/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69238-1503Erythromycin EthylsuccinateErythromycinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1503Erythromycin EthylsuccinateErythromycinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1503Erythromycin EthylsuccinateErythromycinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1504Erythromycin EthylsuccinateErythromycinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1504Erythromycin EthylsuccinateErythromycinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1504Erythromycin EthylsuccinateErythromycinAmneal Pharmaceuticals NY LLCANDACurrent