FDA.reportPublic FDA data

Application 206079

Type
ANDA
Sponsor
IMPAX LABS INC

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
0115-1742GlyburideGlyburideAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1742GlyburideGlyburideAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1742GlyburideGlyburideImpax GenericsANDACurrent
0115-1743GlyburideGlyburideAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1743GlyburideGlyburideAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1743GlyburideGlyburideImpax GenericsANDACurrent
0115-1744GlyburideGlyburideAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1744GlyburideGlyburideAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1744GlyburideGlyburideImpax GenericsANDACurrent
68071-4142GlyburideGlyburideNuCare Pharmceuticals,Inc.ANDACurrent
68071-4142GlyburideGlyburideNuCare Pharmceuticals,Inc.ANDACurrent