FDA.reportPublic FDA data

Application 078939

Type
ANDA
Sponsor
LUPIN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ETHAMBUTOL HYDROCHLORIDEETHAMBUTOL HYDROCHLORIDETABLET;ORAL100MGNoNo
002ETHAMBUTOL HYDROCHLORIDEETHAMBUTOL HYDROCHLORIDETABLET;ORAL400MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-5140Ethambutol HydrochlorideEthambutol HydrochlorideA-S Medication SolutionsANDACurrent
50090-5140Ethambutol HydrochlorideEthambutol HydrochlorideA-S Medication SolutionsANDACurrent
50090-5142Ethambutol HydrochlorideEthambutol HydrochlorideA-S Medication SolutionsANDACurrent
50090-5142Ethambutol HydrochlorideEthambutol HydrochlorideA-S Medication SolutionsANDACurrent
68084-280Ethambutol HydrochlorideEthambutol HydrochlorideAmerican Health PackagingANDACurrent
68084-280Ethambutol HydrochlorideEthambutol HydrochlorideAmerican Health PackagingANDACurrent
68084-280Ethambutol HydrochlorideEthambutol HydrochlorideAmerican Health PackagingANDACurrent
68151-0149Ethambutol HydrochlorideEthambutol HydrochlorideCarilion Materials ManagementANDACurrent
68180-280Ethambutol HydrochlorideEthambutol HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-280Ethambutol HydrochlorideEthambutol HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-280Ethambutol HydrochlorideEthambutol HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-281Ethambutol HydrochlorideEthambutol HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-281Ethambutol HydrochlorideEthambutol HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-281Ethambutol HydrochlorideEthambutol HydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
70518-2966Ethambutol HydrochlorideEthambutol HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2966Ethambutol HydrochlorideEthambutol HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-2966Ethambutol HydrochlorideEthambutol HydrochlorideREMEDYREPACK INC.ANDACurrent