FDA.reportPublic FDA data

Application 077571

Type
ANDA
Sponsor
SUN PHARM INDS INC

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
57664-745RepaglinideRepaglinideSun Pharmaceutical Industries, Inc.ANDACurrent
57664-745RepaglinideRepaglinideSun Pharmaceutical Industries, Inc.ANDACurrent
57664-747RepaglinideRepaglinideSun Pharmaceutical Industries, Inc.ANDACurrent
57664-747RepaglinideRepaglinideSun Pharmaceutical Industries, Inc.ANDACurrent
60846-882PrandinRepaglinideGemini Laboratories, LLCANDACurrent
60846-882PrandinRepaglinideAmneal Pharmaceuticals LLCANDACurrent
60846-882PrandinRepaglinideAmneal Pharmaceuticals LLCANDACurrent
60846-884PrandinRepaglinideGemini Laboratories, LLCANDACurrent
60846-884PrandinRepaglinideAmneal Pharmaceuticals LLCANDACurrent
60846-884PrandinRepaglinideAmneal Pharmaceuticals LLCANDACurrent
68084-954RepaglinideRepaglinideAmerican Health PackagingANDACurrent
68084-954RepaglinideRepaglinideAmerican Health PackagingANDACurrent
68084-954RepaglinideRepaglinideAmerican Health PackagingANDACurrent
68084-967RepaglinideRepaglinideAmerican Health PackagingANDACurrent
68084-967RepaglinideRepaglinideAmerican Health PackagingANDACurrent
68084-967RepaglinideRepaglinideAmerican Health PackagingANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44534ORIG2013-09-24
18467ORIG2013-07-12
9064ORIG2013-07-12
9063ORIG2007-08-14