FDA.reportPublic FDA data

Application 074226

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLIPIZIDEGLIPIZIDETABLET;ORAL5MGNoNo
002GLIPIZIDEGLIPIZIDETABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-1105GlipizideglipizideMylan Pharmaceuticals Inc.ANDACurrent
0378-1105GlipizideglipizideMylan Pharmaceuticals Inc.ANDACurrent
0378-1105GlipizideglipizideMylan Pharmaceuticals Inc.ANDACurrent
0378-1110GlipizideglipizideMylan Pharmaceuticals Inc.ANDACurrent
0378-1110GlipizideglipizideMylan Pharmaceuticals Inc.ANDACurrent
0378-1110GlipizideglipizideMylan Pharmaceuticals Inc.ANDACurrent
0615-3595GlipizideGlipizideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-3596GlipizideGlipizideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
43353-369GlipizideglipizideAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-369GlipizideglipizideAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-379GlipizideglipizideAphena Pharma Solutions - Tennessee, LLCANDACurrent
51079-810GlipizideglipizideMylan Institutional Inc.ANDACurrent
51079-810GlipizideglipizideMylan Institutional Inc.ANDACurrent
51079-810GlipizideglipizideMylan Institutional Inc.ANDACurrent
51079-810GlipizideglipizideMylan Institutional Inc.ANDACurrent
51079-811GlipizideglipizideMylan Institutional Inc.ANDACurrent
51079-811GlipizideglipizideMylan Institutional Inc.ANDACurrent
51079-811GlipizideglipizideMylan Institutional Inc.ANDACurrent
51079-811GlipizideglipizideMylan Institutional Inc.ANDACurrent
51079-811GlipizideglipizideMylan Institutional Inc.ANDACurrent
55154-5224GlipizideglipizideCardinal HealthANDACurrent
55154-5224GlipizideglipizideCardinal HealthANDACurrent
61145-202GlipizideglipizideRePharm PharmaceuticalsANDACurrent
61145-203GlipizideglipizideRePharm PharmaceuticalsANDACurrent
61919-286GlipizideGlipizideDIRECT RXANDACurrent