FDA.reportPublic FDA data

Application 090308

Type
ANDA
Sponsor
BARR LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLOZAPINECLOZAPINETABLET, ORALLY DISINTEGRATING;ORAL25MGNoNo
002CLOZAPINECLOZAPINETABLET, ORALLY DISINTEGRATING;ORAL100MGNoYes
003CLOZAPINECLOZAPINETABLET, ORALLY DISINTEGRATING;ORAL12.5MGNoNo
004CLOZAPINECLOZAPINETABLET, ORALLY DISINTEGRATING;ORAL150MGNoNo
005CLOZAPINECLOZAPINETABLET, ORALLY DISINTEGRATING;ORAL200MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-5416ClozapineClozapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5416ClozapineClozapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5416ClozapineClozapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5416ClozapineClozapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5416ClozapineClozapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5417ClozapineClozapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5417ClozapineClozapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5417ClozapineClozapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5417ClozapineClozapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5417ClozapineClozapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5419ClozapineClozapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5419ClozapineClozapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5419ClozapineClozapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5419ClozapineClozapineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5419ClozapineClozapineTeva Pharmaceuticals USA, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
54157ORIG2018-05-11
44549ORIG2015-11-30
9265ORIG2015-11-30