FDA.reportPublic FDA data

Application 077243

Type
ANDA
Sponsor
BARR LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OLANZAPINEOLANZAPINETABLET, ORALLY DISINTEGRATING;ORAL5MGNoNo
002OLANZAPINEOLANZAPINETABLET, ORALLY DISINTEGRATING;ORAL10MGNoNo
003OLANZAPINEOLANZAPINETABLET, ORALLY DISINTEGRATING;ORAL15MGNoNo
004OLANZAPINEOLANZAPINETABLET, ORALLY DISINTEGRATING;ORAL20MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-5245OlanzapineOlanzapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5245OlanzapineOlanzapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5245OlanzapineOlanzapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5245OlanzapineOlanzapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5245OlanzapineOlanzapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5245OlanzapineOlanzapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5245OlanzapineOlanzapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5246OlanzapineOlanzapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5246OlanzapineOlanzapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5246OlanzapineOlanzapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5246OlanzapineOlanzapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5246OlanzapineOlanzapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5246OlanzapineOlanzapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5246OlanzapineOlanzapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5247OlanzapineOlanzapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5247OlanzapineOlanzapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5247OlanzapineOlanzapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5247OlanzapineOlanzapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5247OlanzapineOlanzapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5247OlanzapineOlanzapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5247OlanzapineOlanzapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5248OlanzapineOlanzapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5248OlanzapineOlanzapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5248OlanzapineOlanzapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5248OlanzapineOlanzapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5248OlanzapineOlanzapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5248OlanzapineOlanzapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5248OlanzapineOlanzapineTeva Pharmaceuticals USA, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9024ORIG2006-11-14