FDA.reportPublic FDA data

Application 210954

Type
ANDA
Sponsor
AMNEAL PHARMS CO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ERYTHROMYCINERYTHROMYCINTABLET, DELAYED RELEASE;ORAL250MGNoNo
002ERYTHROMYCINERYTHROMYCINTABLET, DELAYED RELEASE;ORAL333MGNoNo
003ERYTHROMYCINERYTHROMYCINTABLET, DELAYED RELEASE;ORAL500MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-4616ErythromycinErythromycinA-S Medication SolutionsANDACurrent
69238-1471ErythromycinErythromycinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1471ErythromycinErythromycinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1471ErythromycinErythromycinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1471ErythromycinErythromycinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1471ErythromycinErythromycinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1472ErythromycinErythromycinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1472ErythromycinErythromycinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1472ErythromycinErythromycinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1472ErythromycinErythromycinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1472ErythromycinErythromycinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1473ErythromycinErythromycinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1473ErythromycinErythromycinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1473ErythromycinErythromycinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1473ErythromycinErythromycinAmneal Pharmaceuticals NY LLCANDACurrent
69238-1473ErythromycinErythromycinAmneal Pharmaceuticals NY LLCANDACurrent