FDA.reportPublic FDA data

Application 202112

Type
ANDA
Sponsor
INDOCO REMEDIES

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLIMEPIRIDEGLIMEPIRIDETABLET;ORAL1MGNoNo
002GLIMEPIRIDEGLIMEPIRIDETABLET;ORAL2MGNoNo
003GLIMEPIRIDEGLIMEPIRIDETABLET;ORAL4MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-3172GlimepirideGlimepirideA-S Medication SolutionsANDACurrent
50090-3172GlimepirideGlimepirideA-S Medication SolutionsANDACurrent
50090-3189GlimepirideGlimepirideA-S Medication SolutionsANDACurrent
50090-3189GlimepirideGlimepirideA-S Medication SolutionsANDACurrent
51655-381GlimepirideGlimepirideNorthwind PharmaceuticalsANDACurrent
68071-3024GlimepirideGlimepirideNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3239GlimepirideGlimepirideNuCare Pharmaceuticals, Inc.ANDACurrent
69543-123GlimepirideGlimepirideVirtus PharmaceuticalsANDACurrent
69543-123GlimepirideGlimepirideVirtus PharmaceuticalsANDACurrent
69543-124GlimepirideGlimepirideVirtus PharmaceuticalsANDACurrent
69543-124GlimepirideGlimepirideVirtus PharmaceuticalsANDACurrent
69543-125GlimepirideGlimepirideVirtus PharmaceuticalsANDACurrent
69543-125GlimepirideGlimepirideVirtus PharmaceuticalsANDACurrent