FDA.reportPublic FDA data

Application 091517

Type
ANDA
Sponsor
BOSCOGEN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001REPAGLINIDEREPAGLINIDETABLET;ORAL0.5MGNoNo
002REPAGLINIDEREPAGLINIDETABLET;ORAL1MGNoNo
003REPAGLINIDEREPAGLINIDETABLET;ORAL2MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51991-853REPAGLINIDEREPAGLINIDEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-853REPAGLINIDEREPAGLINIDEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-854REPAGLINIDEREPAGLINIDEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-854REPAGLINIDEREPAGLINIDEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-855REPAGLINIDEREPAGLINIDEBreckenridge Pharmaceutical, Inc.ANDACurrent
51991-855REPAGLINIDEREPAGLINIDEBreckenridge Pharmaceutical, Inc.ANDACurrent
60429-484REPAGLINIDEREPAGLINIDEGolden State Medical Supply, Inc.ANDACurrent
60429-484REPAGLINIDEREPAGLINIDEGolden State Medical Supply, Inc.ANDACurrent
60429-484REPAGLINIDEREPAGLINIDEGolden State Medical Supply, Inc.ANDACurrent
60429-485REPAGLINIDEREPAGLINIDEGolden State Medical Supply, Inc.ANDACurrent
60429-485REPAGLINIDEREPAGLINIDEGolden State Medical Supply, Inc.ANDACurrent
60429-485REPAGLINIDEREPAGLINIDEGolden State Medical Supply, Inc.ANDACurrent
60429-486REPAGLINIDEREPAGLINIDEGolden State Medical Supply, Inc.ANDACurrent
60429-486REPAGLINIDEREPAGLINIDEGolden State Medical Supply, Inc.ANDACurrent
60429-486REPAGLINIDEREPAGLINIDEGolden State Medical Supply, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31537ORIG2015-04-27
18543ORIG2015-04-27