FDA.reportPublic FDA data

Application 209308

Type
ANDA
Sponsor
BRECKENRIDGE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLOBAZAMCLOBAZAMTABLET;ORAL10MGNoNo
002CLOBAZAMCLOBAZAMTABLET;ORAL20MGNoNo
003CLOBAZAMCLOBAZAMTABLET;ORAL5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51991-900clobazamCLOBAZAMBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-900clobazamCLOBAZAMBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-900clobazamCLOBAZAMBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-900clobazamCLOBAZAMBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-900clobazamCLOBAZAMBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-901clobazamCLOBAZAMBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-901clobazamCLOBAZAMBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-901clobazamCLOBAZAMBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-901clobazamCLOBAZAMBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-901clobazamCLOBAZAMBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-958clobazamCLOBAZAMBreckenridge Pharmaceutical, Inc.ANDACurrent