FDA.reportPublic FDA data

Application 075890

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLYBURIDE (MICRONIZED)GLYBURIDETABLET;ORAL1.5MGNoNo
002GLYBURIDE (MICRONIZED)GLYBURIDETABLET;ORAL3MGNoNo
003GLYBURIDE (MICRONIZED)GLYBURIDETABLET;ORAL6MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9918GlyburideGlyburideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9918GlyburideGlyburideWest-Ward PharmaceuticalsANDACurrent
0143-9918GlyburideGlyburideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9919GlyburideGlyburideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9919GlyburideGlyburideWest-Ward PharmaceuticalsANDACurrent
0143-9919GlyburideGlyburideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9920GlyburideGlyburideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9920GlyburideGlyburideWest-Ward PharmaceuticalsANDACurrent
0143-9920GlyburideGlyburideHikma Pharmaceuticals USA Inc.ANDACurrent
59115-012GlyburideGlyburideHikma PharmaceuticalANDACurrent
59115-012GlyburideGlyburideHikma PharmaceuticalANDACurrent
59115-013GlyburideGlyburideHikma PharmaceuticalANDACurrent
59115-013GlyburideGlyburideHikma PharmaceuticalANDACurrent
59115-014GlyburideGlyburideHikma PharmaceuticalANDACurrent
59115-014GlyburideGlyburideHikma PharmaceuticalANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31044ORIG2003-04-10