FDA.reportPublic FDA data

Application 091220

Type
ANDA
Sponsor
MICRO LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLIMEPIRIDEGLIMEPIRIDETABLET;ORAL1MGNoNo
002GLIMEPIRIDEGLIMEPIRIDETABLET;ORAL2MGNoNo
003GLIMEPIRIDEGLIMEPIRIDETABLET;ORAL3MGNoNo
004GLIMEPIRIDEGLIMEPIRIDETABLET;ORAL4MGNoNo
005GLIMEPIRIDEGLIMEPIRIDETABLET;ORAL6MGNoNo
006GLIMEPIRIDEGLIMEPIRIDETABLET;ORAL8MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8332GlimepirideGlimepirideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8333GlimepirideGlimepirideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8334GlimepirideGlimepirideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
33261-831GlimepirideGlimepirideAidarex Pharmaceuticals LLCANDACurrent
42571-100GlimepirideGlimepirideMicro Labs LimitedANDACurrent
42571-100GlimepirideGlimepirideMicro Labs LimitedANDACurrent
42571-100GlimepirideGlimepirideMicro Labs LimitedANDACurrent
42571-100GlimepirideGlimepirideMicro Labs LimitedANDACurrent
42571-100GlimepirideGlimepirideMicro Labs LimitedANDACurrent
42571-101GlimepirideGlimepirideMicro Labs LimitedANDACurrent
42571-101GlimepirideGlimepirideMicro Labs LimitedANDACurrent
42571-101GlimepirideGlimepirideMicro Labs LimitedANDACurrent
42571-101GlimepirideGlimepirideMicro Labs LimitedANDACurrent
42571-101GlimepirideGlimepirideMicro Labs LimitedANDACurrent
42571-102GlimepirideGlimepirideMicro Labs LimitedANDACurrent
42571-102GlimepirideGlimepirideMicro Labs LimitedANDACurrent
42571-102GlimepirideGlimepirideMicro Labs LimitedANDACurrent
42571-102GlimepirideGlimepirideMicro Labs LimitedANDACurrent
42571-102GlimepirideGlimepirideMicro Labs LimitedANDACurrent
42571-103GlimepirideGlimepirideMicro Labs LimitedANDACurrent
42571-103GlimepirideGlimepirideMicro Labs LimitedANDACurrent
42571-103GlimepirideGlimepirideMicro Labs LimitedANDACurrent
42571-103GlimepirideGlimepirideMicro Labs LimitedANDACurrent
42571-103GlimepirideGlimepirideMicro Labs LimitedANDACurrent
42571-104GlimepirideGlimepirideMicro Labs LimitedANDACurrent
42571-104GlimepirideGlimepirideMicro Labs LimitedANDACurrent
42571-104GlimepirideGlimepirideMicro Labs LimitedANDACurrent
42571-104GlimepirideGlimepirideMicro Labs LimitedANDACurrent
42571-104GlimepirideGlimepirideMicro Labs LimitedANDACurrent
42571-105GlimepirideGlimepirideMicro Labs LimitedANDACurrent
42571-105GlimepirideGlimepirideMicro Labs LimitedANDACurrent
42571-105GlimepirideGlimepirideMicro Labs LimitedANDACurrent
42571-105GlimepirideGlimepirideMicro Labs LimitedANDACurrent
42571-105GlimepirideGlimepirideMicro Labs LimitedANDACurrent
53217-285GlimepirideGlimepirideAidarex Pharmaceuticals LLCANDACurrent
68071-1991GlimepirideGlimepirideNuCare Pharmaceuticals, Inc.ANDACurrent
68788-6801GlimepirideGlimepiridePreferred Pharmaceuticals Inc.ANDACurrent
68788-6801GlimepirideGlimepiridePreferred Pharmaceuticals Inc.ANDACurrent
68788-6818GlimepirideGlimepiridePreferred Pharmaceuticals Inc.ANDACurrent
69452-128GlimepirideGlimepirideBionpharma Inc.ANDACurrent
69452-129GlimepirideGlimepirideBionpharma Inc.ANDACurrent
69452-130GlimepirideGlimepirideBionpharma Inc.ANDACurrent
71335-1885GlimepirideGlimepirideBryant Ranch PrepackANDACurrent
71335-1885GlimepirideGlimepirideBryant Ranch PrepackANDACurrent
71335-1886GlimepirideGlimepirideBryant Ranch PrepackANDACurrent