Application 090252

Type
ANDA
Sponsor
MYLAN

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
0378-3122RepagliniderepaglinideMylan Pharmaceuticals Inc.ANDACurrent
0378-3123RepagliniderepaglinideMylan Pharmaceuticals Inc.ANDACurrent
51079-539RepagliniderepaglinideMylan Institutional Inc.ANDACurrent