FDA.reportPublic FDA data

Application 077624

Type
ANDA
Sponsor
MYLAN

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
0378-4011GlimepirideglimepirideMylan Pharmaceuticals IncANDACurrent
0378-4011GlimepirideglimepirideMylan Pharmaceuticals Inc.ANDACurrent
0378-4012GlimepirideglimepirideMylan Pharmaceuticals IncANDACurrent
0378-4012GlimepirideglimepirideMylan Pharmaceuticals Inc.ANDACurrent
0378-4013GlimepirideglimepirideMylan Pharmaceuticals IncANDACurrent
0378-4013GlimepirideglimepirideMylan Pharmaceuticals Inc.ANDACurrent
51079-425GlimepirideglimepirideMylan Institutional Inc.ANDACurrent
51079-425GlimepirideglimepirideMylan Institutional Inc.ANDACurrent
51079-426GlimepirideglimepirideMylan Institutional Inc.ANDACurrent
51079-426GlimepirideglimepirideMylan Institutional Inc.ANDACurrent
55154-5070GlimepirideglimepirideCardinal HealthANDACurrent