FDA.reportPublic FDA data

Application 203499

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLIPIZIDEGLIPIZIDETABLET, EXTENDED RELEASE;ORAL2.5MGNoNo
002GLIPIZIDEGLIPIZIDETABLET, EXTENDED RELEASE;ORAL5MGNoNo
003GLIPIZIDEGLIPIZIDETABLET, EXTENDED RELEASE;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-894GlipizideGlipizideNorthstar Rx LLC.ANDACurrent
16714-894GlipizideGlipizideNorthstar Rx LLC.ANDACurrent
16714-894GlipizideGlipizideNorthstar Rx LLC.ANDACurrent
16714-895GlipizideGlipizideNorthstar Rx LLC.ANDACurrent
16714-895GlipizideGlipizideNorthstar Rx LLC.ANDACurrent
16714-895GlipizideGlipizideNorthstar Rx LLC.ANDACurrent
16714-896GlipizideGlipizideNorthstar Rx LLC.ANDACurrent
16714-896GlipizideGlipizideNorthstar Rx LLC.ANDACurrent
16714-896GlipizideGlipizideNorthstar Rx LLC.ANDACurrent
50090-5377GlipizideGlipizideA-S Medication SolutionsANDACurrent
50090-5377GlipizideGlipizideA-S Medication SolutionsANDACurrent
61919-850GLIPIZIDEGLIPIZIDEDirect_RxANDACurrent
68071-4994GlipizideGlipizideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4994GlipizideGlipizideNuCare Pharmaceuticals,Inc.ANDACurrent
68382-335GlipizideGlipizideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-335GlipizideGlipizideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-335GlipizideGlipizideZydus Pharmaceuticals USA Inc.ANDACurrent
68382-336GlipizideGlipizideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-336GlipizideGlipizideZydus Pharmaceuticals USA Inc.ANDACurrent
68382-336GlipizideGlipizideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-337GlipizideGlipizideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-337GlipizideGlipizideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-337GlipizideGlipizideZydus Pharmaceuticals USA Inc.ANDACurrent
70771-1098GlipizideGlipizideCadila Healthcare LimitedANDACurrent
70771-1098GlipizideGlipizideCadila Healthcare LimitedANDACurrent
70771-1098GlipizideGlipizideZydus Lifesciences LimitedANDACurrent
70771-1098GlipizideGlipizideCadila Healthcare LimitedANDACurrent
70771-1099GlipizideGlipizideCadila Healthcare LimitedANDACurrent
70771-1099GlipizideGlipizideCadila Healthcare LimitedANDACurrent
70771-1099GlipizideGlipizideZydus Lifesciences LimitedANDACurrent
70771-1099GlipizideGlipizideCadila Healthcare LimitedANDACurrent
70771-1100GlipizideGlipizideCadila Healthcare LimitedANDACurrent
70771-1100GlipizideGlipizideCadila Healthcare LimitedANDACurrent
70771-1100GlipizideGlipizideZydus Lifesciences LimitedANDACurrent
70771-1100GlipizideGlipizideCadila Healthcare LimitedANDACurrent