FDA.reportPublic FDA data

Application 076802

Type
ANDA
Sponsor
TEVA

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
0093-7254GlimepirideGlimepirideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7254GlimepirideGlimepirideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7255GlimepirideGlimepirideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7255GlimepirideGlimepirideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7256GlimepirideGlimepirideTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7256GlimepirideGlimepirideTeva Pharmaceuticals USA, Inc.ANDACurrent
42708-083GlimepirideGlimepirideQPharma IncANDACurrent
42708-083GlimepirideGlimepirideQPharma IncANDACurrent
66116-432GlimepirideGlimepirideMedVantx, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43107ORIG2012-01-27
8967ORIG2005-10-11