FDA.reportPublic FDA data

Application 077870

Type
ANDA
Sponsor
AUROBINDO PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLYBURIDE AND METFORMIN HYDROCHLORIDEGLYBURIDE; METFORMIN HYDROCHLORIDETABLET;ORAL1.25MG;250MGNoNo
002GLYBURIDE AND METFORMIN HYDROCHLORIDEGLYBURIDE; METFORMIN HYDROCHLORIDETABLET;ORAL2.5MG;500MGNoYes
003GLYBURIDE AND METFORMIN HYDROCHLORIDEGLYBURIDE; METFORMIN HYDROCHLORIDETABLET;ORAL5MG;500MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-0887Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideA-S Medication SolutionsANDACurrent
50090-0887Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideA-S Medication SolutionsANDACurrent
50090-0888Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideA-S Medication SolutionsANDACurrent
50090-2030Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideA-S Medication SolutionsANDACurrent
50090-2030Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideA-S Medication SolutionsANDACurrent
50090-2031Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideA-S Medication SolutionsANDACurrent
50090-2031Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideA-S Medication SolutionsANDACurrent
50090-2031Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideA-S Medication SolutionsANDACurrent
50268-355Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideAvPAKANDACurrent
50268-356Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideAvPAKANDACurrent
50268-357Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideAvPAKANDACurrent
50268-357Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideAvPAKANDACurrent
50436-0024Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideUnit Dose ServicesANDACurrent
51655-942Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideNorthwind PharmaceuticalsANDACurrent
51655-942Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideNorthwind PharmaceuticalsANDACurrent
55700-395Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-612Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-612Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideLake Erie Medical DBA Quality Care Products LLCANDACurrent
57237-023Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideRising Health, LLCANDACurrent
57237-023Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideRising Health, LLCANDACurrent
57237-023Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideRising Health, LLCANDACurrent
57237-023Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideRising Health, LLCANDACurrent
57237-023Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideRising Health, LLCANDACurrent
57237-024Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideRising Health, LLCANDACurrent
57237-024Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideRising Health, LLCANDACurrent
57237-024Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideRising Health, LLCANDACurrent
57237-024Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideRising Health, LLCANDACurrent
57237-024Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideRising Health, LLCANDACurrent
57237-025Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideRising Health, LLCANDACurrent
57237-025Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideRising Health, LLCANDACurrent
57237-025Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideRising Health, LLCANDACurrent
57237-025Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideRising Health, LLCANDACurrent
57237-025Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideRising Health, LLCANDACurrent
61919-418GLYBURIDE AND METFORMIN HYDROCHLORIDEGLYBURIDE AND METFORMIN HYDROCHLORIDEDirectRXANDACurrent
61919-418GLYBURIDE AND METFORMIN HYDROCHLORIDEGLYBURIDE AND METFORMIN HYDROCHLORIDEDirectRXANDACurrent
65862-080Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-080Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-080Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-080Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-081Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-081Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-081Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-081Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-082Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-082Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-082Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideAurobindo Pharma LimitedANDACurrent
65862-082Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideAurobindo Pharma LimitedANDACurrent
68071-1836Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1836Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1967Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1967Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-4093Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4109Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4444Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4453Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4718Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4718Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4828Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4828Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-6426Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7180Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7180Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7180Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7180Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-7180Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-9716Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9728Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9966Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-9966Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-9966Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
70934-570Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
70934-959Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-0179Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideBryant Ranch PrepackANDACurrent
71335-0179Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideBryant Ranch PrepackANDACurrent
71335-0179Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideBryant Ranch PrepackANDACurrent
71335-0360Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideBryant Ranch PrepackANDACurrent
71335-0360Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideBryant Ranch PrepackANDACurrent
71335-0360Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideBryant Ranch PrepackANDACurrent
71335-0967Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideBryant Ranch PrepackANDACurrent
71335-0967Glyburide and Metformin HydrochlorideGlyburide and Metformin HydrochlorideBryant Ranch PrepackANDACurrent