FDA.reportPublic FDA data

Application 213628

Type
ANDA
Sponsor
ORANGE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ERYTHROMYCINERYTHROMYCINTABLET;ORAL250MGNoNo
002ERYTHROMYCINERYTHROMYCINTABLET;ORAL500MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
71209-100ErythromycinErythromycinCadila Pharmaceuticals LimitedANDACurrent
71209-100ErythromycinErythromycinCadila Pharmaceuticals LimitedANDACurrent
71209-101ErythromycinErythromycinCadila Pharmaceuticals LimitedANDACurrent
71209-101ErythromycinErythromycinCadila Pharmaceuticals LimitedANDACurrent
72241-036ErythromycinErythromycinModavar Pharmaceuticals LLCANDACurrent
72241-037ErythromycinErythromycinModavar Pharmaceuticals LLCANDACurrent
73082-010ErythromycinErythromycinOrange Pharmaceuticals USA LLCANDACurrent
73082-020ErythromycinErythromycinOrange Pharmaceuticals USA LLCANDACurrent
75834-242ErythromycinErythromycinNivagen Pharmaceuticals, Inc.ANDACurrent
75834-243ErythromycinErythromycinNivagen Pharmaceuticals, Inc.ANDACurrent