FDA.reportPublic FDA data

Application 204720

Type
ANDA
Sponsor
UNIQUE PHARM LABS

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
50090-5040GlipizideGlipizideA-S Medication SolutionsANDACurrent
50090-5040GlipizideGlipizideA-S Medication SolutionsANDACurrent
50090-5806GlipizideGlipizideA-S Medication SolutionsANDACurrent
51655-337GlipizideGlipizideNorthwind PharmaceuticalsANDACurrent
51655-337GlipizideGlipizideNorthwind PharmaceuticalsANDACurrent
60760-165GlipizideGlipizideSt. Mary's Medical Park PharmacyANDACurrent
60760-568GlipizideGlipizideSt. Mary's Medical Park PharmacyANDACurrent
61919-713GLIPIZIDEGLIPIZIDEDirect_RxANDACurrent
61919-713GLIPIZIDEGLIPIZIDEDirect_RxANDACurrent
61919-713GLIPIZIDEGLIPIZIDEDirect_RxANDACurrent
61919-715GlipizideGlipizideDirect_RxANDACurrent
61919-715GlipizideGlipizideDirect_RxANDACurrent
61919-715GlipizideGlipizideDirect_RxANDACurrent
63629-8181GlipizideGlipizideBryant Ranch PrepackANDACurrent
64980-279GlipizideGlipizideRising Pharmaceuticals, Inc.ANDACurrent
64980-280GlipizideGlipizideRising Pharmaceuticals, Inc.ANDACurrent
64980-281GlipizideGlipizideRising Pharmaceuticals, Inc.ANDACurrent
68071-4378GlipizideGlipizideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4378GlipizideGlipizideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4498GlipizideGlipizideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4498GlipizideGlipizideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4498GlipizideGlipizideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7856GlipizideGlipizidePreferred Pharmaceuticals Inc.ANDACurrent
68788-7856GlipizideGlipizidePreferred Pharmaceuticals Inc.ANDACurrent
70518-1063GlipizideGlipizideREMEDYREPACK INC.ANDACurrent
70518-1063GlipizideGlipizideREMEDYREPACK INC.ANDACurrent
70518-1063GlipizideGlipizideREMEDYREPACK INC.ANDACurrent
70518-1063GlipizideGlipizideREMEDYREPACK INC.ANDACurrent
70518-1063GlipizideGlipizideREMEDYREPACK INC.ANDACurrent
70518-1848GlipizideGlipizideREMEDYREPACK INC.ANDACurrent
70518-1848GlipizideGlipizideREMEDYREPACK INC.ANDACurrent
70518-1848GlipizideGlipizideREMEDYREPACK INC.ANDACurrent
70518-1848GlipizideGlipizideREMEDYREPACK INC.ANDACurrent
70518-1848GlipizideGlipizideREMEDYREPACK INC.ANDACurrent
70518-2308GlipizideGlipizideREMEDYREPACK INC.ANDACurrent
70518-2308GlipizideGlipizideREMEDYREPACK INC.ANDACurrent
70934-272GlipizideGlipizideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-272GlipizideGlipizideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-1031GlipizideGlipizideBryant Ranch PrepackANDACurrent
71335-1031GlipizideGlipizideBryant Ranch PrepackANDACurrent
71335-1031GlipizideGlipizideBryant Ranch PrepackANDACurrent
71335-1042GlipizideGlipizideBryant Ranch PrepackANDACurrent
71335-1042GlipizideGlipizideBryant Ranch PrepackANDACurrent
71335-1042GlipizideGlipizideBryant Ranch PrepackANDACurrent
71335-1130GlipizideGlipizideBryant Ranch PrepackANDACurrent
71335-1130GlipizideGlipizideBryant Ranch PrepackANDACurrent
71335-1130GlipizideGlipizideBryant Ranch PrepackANDACurrent