FDA.report

Application 090937

Type
ANDA
Sponsor
HERITAGE PHARMS INC

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001GLYBURIDEGLYBURIDETABLET;ORAL1.25MGNoNo
002GLYBURIDEGLYBURIDETABLET;ORAL2.5MGNoNo
003GLYBURIDEGLYBURIDETABLET;ORAL5MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-232GlyburideGlyburideBlenheim Pharmacal, Inc.ANDACurrent
10544-300GlyburideGlyburideBlenheim Pharmacal, Inc.ANDACurrent
23155-056GlyburideGlyburideHeritage Pharmaceuticals Inc.ANDACurrent
23155-056GLYBURIDEGLYBURIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-056GLYBURIDEGLYBURIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-057GLYBURIDEGLYBURIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-057GlyburideGlyburideHeritage Pharmaceuticals Inc.ANDACurrent
23155-057GLYBURIDEGLYBURIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-058GLYBURIDEGLYBURIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-058GlyburideGlyburideHeritage Pharmaceuticals Inc.ANDACurrent
23155-058GLYBURIDEGLYBURIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
33261-209GlyburideGlyburideAidarex Pharmaceuticals LLCANDACurrent
33261-813GlyburideGlyburideAidarex Pharmaceuticals LLCANDACurrent
42254-090GlyburideGlyburideRebel Distributors CorpANDACurrent
50090-0495GLYBURIDEGLYBURIDEA-S Medication SolutionsANDACurrent
50090-0495GLYBURIDEGLYBURIDEA-S Medication SolutionsANDACurrent
50090-5776GLYBURIDEGLYBURIDEA-S Medication SolutionsANDACurrent
50436-6408GlyburideGlyburideUnit Dose ServicesANDACurrent
53002-4170GLYBURIDEGLYBURIDERPK Pharmaceuticals, Inc.ANDACurrent
55700-725GlyburideGlyburideQuality Care Products, LLCANDACurrent
55700-725GlyburideGlyburideQuality Care Products, LLCANDACurrent
55700-725GlyburideGlyburideQuality Care Products, LLCANDACurrent
55700-725GlyburideGlyburideQuality Care Products, LLCANDACurrent
61919-330GLYBURIDEGLYBURIDEDirectRXANDACurrent
61919-330GLYBURIDEGLYBURIDEDirectRXANDACurrent
61919-378GLYBURIDEGLYBURIDEDirectRXANDACurrent
61919-378GlyburideGlyburideDirect_RxANDACurrent
61919-378GlyburideGlyburideDirect_RxANDACurrent
61919-378GlyburideGlyburideDirect_RxANDACurrent
63187-659GlyburideGlyburideProficient Rx LPANDACurrent
63187-659GlyburideGlyburideProficient Rx LPANDACurrent
63187-667GlyburideGlyburideProficient Rx LPANDACurrent
63187-667GlyburideGlyburideProficient Rx LPANDACurrent
63629-6413GlyburideGlyburideBryant Ranch PrepackANDACurrent
63629-6413GlyburideGLYBURIDEBryant Ranch PrepackANDACurrent
63629-6840GlyburideGLYBURIDEBryant Ranch PrepackANDACurrent
63629-6840GlyburideGlyburideBryant Ranch PrepackANDACurrent
64725-0058GlyburideGlyburideTYA PharmaceuticalsANDACurrent
66267-102GlyburideGlyburideNuCare Pharmaceuticals, Inc.ANDACurrent
66267-102GlyburideGlyburideNuCare Pharmaceuticals, Inc.ANDACurrent
66267-103GlyburideGlyburideNuCare Pharmaceuticals, Inc.ANDACurrent
66267-103GlyburideGlyburideNuCare Pharmaceuticals, Inc.ANDACurrent
66336-028GlyburideGlyburideDispensing Solutions, Inc.ANDACurrent
68071-2589GLYBURIDEGLYBURIDENuCare Pharmaceuticals,Inc.ANDACurrent
68071-2589GLYBURIDEGLYBURIDENuCare Pharmaceuticals,Inc.ANDACurrent
68071-4695GlyburideGlyburideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4695GlyburideGlyburideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4695GlyburideGlyburideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4695GlyburideGlyburideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4730GlyburideGlyburideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4730GlyburideGlyburideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4730GlyburideGlyburideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5029GlyburideGlyburideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5029GlyburideGlyburideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5030GlyburideGlyburideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5030GlyburideGlyburideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5215GLYBURIDEGLYBURIDENuCare Pharmaceuticals,Inc.ANDACurrent
68071-5215GLYBURIDEGLYBURIDENuCare Pharmaceuticals,Inc.ANDACurrent
68071-5217GLYBURIDEGLYBURIDENuCare Pharmaceuticals,Inc.ANDACurrent
68071-5217GLYBURIDEGLYBURIDENuCare Pharmaceuticals,Inc.ANDACurrent
68788-9216GlyburideGlyburidePreferred Pharmaceuticals Inc.ANDACurrent
70518-1201GLYBURIDEGLYBURIDEREMEDYREPACK INC.ANDACurrent
70518-1201GLYBURIDEGLYBURIDEREMEDYREPACK INC.ANDACurrent
70518-1201GLYBURIDEGLYBURIDEREMEDYREPACK INC.ANDACurrent
70518-1201GlyburideGlyburideREMEDYREPACK INC.ANDACurrent
70518-1201GlyburideGlyburideREMEDYREPACK INC.ANDACurrent
70518-1201GlyburideGlyburideREMEDYREPACK INC.ANDACurrent
70518-1201GlyburideGlyburideREMEDYREPACK INC.ANDACurrent
70518-1513GlyburideGlyburideREMEDYREPACK INC.ANDACurrent
70518-1513GlyburideGlyburideREMEDYREPACK INC.ANDACurrent
70518-1513GlyburideGlyburideREMEDYREPACK INC.ANDACurrent
70518-1513GLYBURIDEGLYBURIDEREMEDYREPACK INC.ANDACurrent
70518-1513GLYBURIDEGLYBURIDEREMEDYREPACK INC.ANDACurrent
70518-1513GLYBURIDEGLYBURIDEREMEDYREPACK INC.ANDACurrent
70518-1646GlyburideGlyburideREMEDYREPACK INC.ANDACurrent
70518-1646GLYBURIDEGLYBURIDEREMEDYREPACK INC.ANDACurrent
70518-1646GLYBURIDEGLYBURIDEREMEDYREPACK INC.ANDACurrent
70518-1646GLYBURIDEGLYBURIDEREMEDYREPACK INC.ANDACurrent
70518-1646GLYBURIDEGLYBURIDEREMEDYREPACK INC.ANDACurrent
70518-1646GlyburideGlyburideREMEDYREPACK INC.ANDACurrent