FDA.reportPublic FDA data

Application 205248

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NATEGLINIDENATEGLINIDETABLET;ORAL60MGNoNo
002NATEGLINIDENATEGLINIDETABLET;ORAL120MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68382-721NateglinideNateglinideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-721NateglinideNateglinideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-721NateglinideNateglinideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-722NateglinideNateglinideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-722NateglinideNateglinideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-722NateglinideNateglinideZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1015NateglinideNateglinideCadila Healthcare LimitedANDACurrent
70771-1015NateglinideNateglinideZydus Lifesciences LimitedANDACurrent
70771-1015NateglinideNateglinideCadila Healthcare LimitedANDACurrent
70771-1015NateglinideNateglinideCadila Healthcare LimitedANDACurrent
70771-1016NateglinideNateglinideCadila Healthcare LimitedANDACurrent
70771-1016NateglinideNateglinideZydus Lifesciences LimitedANDACurrent
70771-1016NateglinideNateglinideCadila Healthcare LimitedANDACurrent
70771-1016NateglinideNateglinideCadila Healthcare LimitedANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32648ORIG2016-07-11