FDA.report

Application 078181

Type
ANDA
Sponsor
ACCORD HLTHCARE

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001GLIMEPIRIDEGLIMEPIRIDETABLET;ORAL1MGNoNo
002GLIMEPIRIDEGLIMEPIRIDETABLET;ORAL2MGNoNo
003GLIMEPIRIDEGLIMEPIRIDETABLET;ORAL4MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
16729-001GlimepirideGlimepirideAccord Healthcare IncANDACurrent
16729-001GlimepirideGlimepirideAccord Healthcare IncANDACurrent
16729-002GlimepirideGlimepirideAccord Healthcare IncANDACurrent
16729-002GlimepirideGlimepirideAccord Healthcare IncANDACurrent
16729-003GlimepirideGlimepirideAccord Healthcare IncANDACurrent
16729-003GlimepirideGlimepirideAccord Healthcare IncANDACurrent
43063-587GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-587GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-587GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-587GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-587GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-587GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-630GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-630GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-630GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-630GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-630GlimepirideGlimepiridePD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-1526GlimepirideGlimepirideA-S Medication SolutionsANDACurrent
50090-1526GlimepirideGlimepirideA-S Medication SolutionsANDACurrent
50090-1526GlimepirideGlimepirideA-S Medication SolutionsANDACurrent
50090-1526GlimepirideGlimepirideA-S Medication SolutionsANDACurrent
50090-1526GlimepirideGlimepirideA-S Medication SolutionsANDACurrent
50090-1987GlimepirideGlimepirideA-S Medication SolutionsANDACurrent
50090-1987GlimepirideGlimepirideA-S Medication SolutionsANDACurrent
50090-1987GlimepirideGlimepirideA-S Medication SolutionsANDACurrent
50090-1987GlimepirideGlimepirideA-S Medication SolutionsANDACurrent
50090-3547GlimepirideGlimepirideA-S Medication SolutionsANDACurrent
51655-120GLIMEPIRIDEGLIMEPIRIDENorthwind PharmaceuticalsANDACurrent
51655-120GlimepirideGlimepirideNorthwind Pharmaceuticals, LLCANDACurrent
51655-120GlimepirideGlimepirideNorthwind Pharmaceuticals, LLCANDACurrent
53217-250GlimepirideGlimepirideAidarex Pharmaceuticals LLCANDACurrent
55700-594GlimepirideGlimepirideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-594GlimepirideGlimepirideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-594GlimepirideGlimepirideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-594GlimepirideGlimepirideLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-722GlimepirideGlimepirideQuality Care Products, LLCANDACurrent
55700-722GlimepirideGlimepirideQuality Care Products, LLCANDACurrent
60760-248GlimepirideGlimepirideSt. MaryANDACurrent
60760-248GlimepirideGlimepirideSt. MaryANDACurrent
61919-250GLIMEPIRIDEGLIMEPIRIDEDIRECT RXANDACurrent
61919-250GLIMEPIRIDEGLIMEPIRIDEDIRECT RXANDACurrent
61919-250GLIMEPIRIDEGLIMEPIRIDEDIRECT RXANDACurrent
61919-448GLIMEPIRIDEGLIMEPIRIDEDirectRXANDACurrent
61919-448GLIMEPIRIDEGLIMEPIRIDEDircet_RxANDACurrent
61919-448GLIMEPIRIDEGLIMEPIRIDEDirect_RxANDACurrent
61919-448GLIMEPIRIDEGLIMEPIRIDEDirect_RxANDACurrent
61919-448GLIMEPIRIDEGLIMEPIRIDEDircet_RxANDACurrent
61919-448GLIMEPIRIDEGLIMEPIRIDEDircet_RxANDACurrent
61919-723GLIMEPIRIDEGLIMEPIRIDEDIRECT RXANDACurrent
61919-723GLIMEPIRIDEGLIMEPIRIDEDirect_RxANDACurrent
63187-486GlimepirideGlimepirideProficient Rx LPANDACurrent
63187-486GlimepirideGlimepirideProficient Rx LPANDACurrent
63187-486GlimepirideGlimepirideProficient Rx LPANDACurrent
63187-486GlimepirideGlimepirideProficient Rx LPANDACurrent
63187-641GlimepirideGlimepirideProficient Rx LPANDACurrent
63187-641GlimepirideGlimepirideProficient Rx LPANDACurrent
63187-641GlimepirideGlimepirideProficient Rx LPANDACurrent
63187-698GlimepirideGlimepirideProficient Rx LPANDACurrent
63187-698GlimepirideGlimepirideProficient Rx LPANDACurrent
63187-698GlimepirideGlimepirideProficient Rx LPANDACurrent
63187-698GlimepirideGlimepirideProficient Rx LPANDACurrent
63629-5650GlimepirideGlimepirideBryant Ranch PrepackANDACurrent
63629-5650GlimepirideGlimepirideBryant Ranch PrepackANDACurrent
63629-5650GlimepirideGlimepirideBryant Ranch PrepackANDACurrent
67296-1246GlimepirideGlimepirideRedPharm Drug, Inc.ANDACurrent
67296-1246GlimepirideGlimepirideRedPharm Drug, Inc.ANDACurrent
67296-1246GlimepirideGlimepirideRedPharm Drug, Inc.ANDACurrent
67296-1247GlimepirideGlimepirideRedPharm Drug, Inc.ANDACurrent
67296-1247GlimepirideGlimepirideRedPharm Drug, Inc.ANDACurrent
67296-1247GlimepirideGlimepirideRedPharm Drug, Inc.ANDACurrent
68001-177GlimepirideGlimepirideBluePoint LaboratoriesANDACurrent
68001-177GlimepirideGlimepirideBluePoint LaboratoriesANDACurrent
68001-177GlimepirideGlimepirideBluePoint LaboratoriesANDACurrent
68001-177GlimepirideGlimepirideBluePoint LaboratoriesANDACurrent
68001-178GlimepirideGlimepirideBluePoint LaboratoriesANDACurrent
68001-178GlimepirideGlimepirideBluePoint LaboratoriesANDACurrent
68001-178GlimepirideGlimepirideBluePoint LaboratoriesANDACurrent
68001-178GlimepirideGlimepirideBluePoint LaboratoriesANDACurrent
68001-179GlimepirideGlimepirideBluePoint LaboratoriesANDACurrent
68001-179GlimepirideGlimepirideBluePoint LaboratoriesANDACurrent