FDA.reportPublic FDA data

Application 076057

Type
ANDA
Sponsor
BARR

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0555-0923Ethambutol HydrochlorideEthambutol HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0923Ethambutol HydrochlorideEthambutol HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0923Ethambutol HydrochlorideEthambutol HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0923Ethambutol HydrochlorideEthambutol HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
70518-0751Ethambutol HydrochlorideEthambutol HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0751Ethambutol HydrochlorideEthambutol HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0751Ethambutol HydrochlorideEthambutol HydrochlorideREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8856ORIG2003-04-16