FDA.reportPublic FDA data

Application 203379

Type
ANDA
Sponsor
CADILA PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLYBURIDEGLYBURIDETABLET;ORAL1.25MGNoNo
002GLYBURIDEGLYBURIDETABLET;ORAL2.5MGNoNo
003GLYBURIDEGLYBURIDETABLET;ORAL5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-6196GlyburideGlyburideA-S Medication SolutionsANDACurrent
50090-6196GlyburideGlyburideA-S Medication SolutionsANDACurrent
70518-2644GLYBURIDEGLYBURIDEREMEDYREPACK INC.ANDACurrent
70518-2644GLYBURIDEGLYBURIDEREMEDYREPACK INC.ANDACurrent
70518-2644GLYBURIDEGLYBURIDEREMEDYREPACK INC.ANDACurrent
70518-3504GlyburideGlyburideREMEDYREPACK INC.ANDACurrent
70518-3504GlyburideGlyburideREMEDYREPACK INC.ANDACurrent
70934-569GLYBURIDEGLYBURIDEDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71209-009GlyburideGlyburideCadila Pharmaceuticals LimitedANDACurrent
71209-009GlyburideGlyburideCadila Pharmaceuticals LimitedANDACurrent
71209-009GlyburideGlyburideCadila Pharmaceuticals LimitedANDACurrent
71209-009GlyburideGlyburideCadila Pharmaceuticals LimitedANDACurrent
71209-010GlyburideGlyburideCadila Pharmaceuticals LimitedANDACurrent
71209-010GlyburideGlyburideCadila Pharmaceuticals LimitedANDACurrent
71209-010GlyburideGlyburideCadila Pharmaceuticals LimitedANDACurrent
71209-010GlyburideGlyburideCadila Pharmaceuticals LimitedANDACurrent
71209-011GlyburideGlyburideCadila Pharmaceuticals LimitedANDACurrent
71209-011GlyburideGlyburideCadila Pharmaceuticals LimitedANDACurrent
71209-011GlyburideGlyburideCadila Pharmaceuticals LimitedANDACurrent
71209-011GlyburideGlyburideCadila Pharmaceuticals LimitedANDACurrent
72241-038GlyburideGlyburideModavar Pharmaceuticals LLCANDACurrent
72241-038GlyburideGlyburideModavar Pharmaceuticals LLCANDACurrent
72241-039GlyburideGlyburideModavar Pharmaceuticals LLCANDACurrent
72241-039GlyburideGlyburideModavar Pharmaceuticals LLCANDACurrent
72241-040GlyburideGlyburideModavar Pharmaceuticals LLCANDACurrent
72241-040GlyburideGlyburideModavar Pharmaceuticals LLCANDACurrent
75834-202GLYBURIDEGLYBURIDENivagen Pharmaceuticals, Inc.ANDACurrent
75834-202GLYBURIDEGLYBURIDENivagen Pharmaceuticals, Inc.ANDACurrent
75834-203GLYBURIDEGLYBURIDENivagen Pharmaceuticals, Inc.ANDACurrent
75834-203GLYBURIDEGLYBURIDENivagen Pharmaceuticals, Inc.ANDACurrent
75834-204GLYBURIDEGLYBURIDENivagen Pharmaceuticals, Inc.ANDACurrent
75834-204GLYBURIDEGLYBURIDENivagen Pharmaceuticals, Inc.ANDACurrent