FDA.reportPublic FDA data

Application 076000

Type
ANDA
Sponsor
TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OLANZAPINEOLANZAPINETABLET;ORAL2.5MGNoNo
002OLANZAPINEOLANZAPINETABLET;ORAL5MGNoNo
003OLANZAPINEOLANZAPINETABLET;ORAL7.5MGNoNo
004OLANZAPINEOLANZAPINETABLET;ORAL10MGNoNo
005OLANZAPINEOLANZAPINETABLET;ORAL15MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-5767OlanzapineOlanzapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5767OlanzapineOlanzapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5768OlanzapineOlanzapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5768OlanzapineOlanzapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5769OlanzapineOlanzapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5769OlanzapineOlanzapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5770OlanzapineOlanzapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5770OlanzapineOlanzapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5771OlanzapineOlanzapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5771OlanzapineOlanzapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0615-7670OlanzapineOlanzapineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7671olanzapineolanzapineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7672olanzapineolanzapineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7699OlanzapineOlanzapineNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
42254-203OlanzapineOlanzapineRebel Distributors CorpANDACurrent
42254-204OlanzapineOlanzapineRebel Distributors CorpANDACurrent
42254-205OlanzapineOlanzapineRebel Distributors CorpANDACurrent
42254-222OlanzapineOlanzapineRebel Distributors CorpANDACurrent
49349-931OlanzapineOLANZAPINEREMEDYREPACK INC.ANDACurrent
50090-2693OlanzapineOlanzapineA-S Medication SolutionsANDACurrent
50090-2846OlanzapineOlanzapineA-S Medication SolutionsANDACurrent
64725-5768OlanzapineOlanzapineTYA PharmaceuticalsANDACurrent
68258-7095OlanzapineOlanzapineDispensing Solutions, Inc.ANDACurrent
68258-7096OlanzapineOlanzapineDispensing Solutions, Inc.ANDACurrent
68258-7152OlanzapineOlanzapineDispensing Solutions, Inc.ANDACurrent
68258-7153OlanzapineOlanzapineDispensing Solutions, Inc.ANDACurrent
68258-7154OlanzapineOlanzapineDispensing Solutions, Inc.ANDACurrent
70518-0433OlanzapineOlanzapineREMEDYREPACK INC.ANDACurrent
70518-0477OlanzapineOlanzapineREMEDYREPACK INC.ANDACurrent
70518-0477OlanzapineOlanzapineREMEDYREPACK INC.ANDACurrent