FDA.reportPublic FDA data

Application 021590

Type
NDA
Sponsor
JAZZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FAZACLO ODTCLOZAPINETABLET, ORALLY DISINTEGRATING;ORAL25MGYesNo
002FAZACLO ODTCLOZAPINETABLET, ORALLY DISINTEGRATING;ORAL100MGYesNo
003FAZACLO ODTCLOZAPINETABLET, ORALLY DISINTEGRATING;ORAL50MGNoNo
004FAZACLO ODTCLOZAPINETABLET, ORALLY DISINTEGRATING;ORAL12.5MGYesNo
005FAZACLO ODTCLOZAPINETABLET, ORALLY DISINTEGRATING;ORAL150MGYesNo
006FAZACLO ODTCLOZAPINETABLET, ORALLY DISINTEGRATING;ORAL200MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-3010ClozapineclozapineTeva Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
0093-3011ClozapineclozapineTeva Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
0093-3012ClozapineclozapineTeva Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
0093-3086ClozapineclozapineTeva Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
0093-3086ClozapineclozapineTeva Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
0093-3086ClozapineclozapineTeva Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
0093-3086ClozapineclozapineTeva Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
0093-3087ClozapineclozapineTeva Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
0093-3087ClozapineclozapineTeva Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
0093-3087ClozapineclozapineTeva Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
0093-3087ClozapineclozapineTeva Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
18860-101FazaCloclozapineJazz Pharmaceuticals, Inc.NDACurrent
18860-101FazaCloclozapineJazz Pharmaceuticals, Inc.NDACurrent
18860-101FazaCloclozapineJazz Pharmaceuticals, Inc.NDACurrent
18860-102FazaCloclozapineJazz Pharmaceuticals, Inc.NDACurrent
18860-102FazaCloclozapineJazz Pharmaceuticals, Inc.NDACurrent
18860-104FazaCloclozapineJazz Pharmaceuticals, Inc.NDACurrent
18860-104FazaCloclozapineJazz Pharmaceuticals, Inc.NDACurrent
18860-104FazaCloclozapineJazz Pharmaceuticals, Inc.NDACurrent
18860-105FazaCloclozapineJazz Pharmaceuticals, Inc.NDACurrent
18860-105FazaCloclozapineJazz Pharmaceuticals, Inc.NDACurrent
18860-106FazaCloclozapineJazz Pharmaceuticals, Inc.NDACurrent
18860-106FazaCloclozapineJazz Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
62579SUPPL2020-04-15
62574SUPPL2020-04-15
57307SUPPL2019-01-22
47371SUPPL2017-03-02
47353SUPPL2017-02-27
37303SUPPL2015-10-22
28210SUPPL2015-10-02
37302SUPPL2015-09-16
37298SUPPL2015-09-16
28209SUPPL2015-09-16
28203SUPPL2015-09-16
24004ORIG2015-09-16
37301SUPPL2013-07-23
28207SUPPL2013-07-22
28208SUPPL2012-01-12
15843SUPPL2012-01-09
28206SUPPL2010-12-06
15842SUPPL2010-12-04
28205SUPPL2010-09-13
15841SUPPL2010-09-10
28204SUPPL2010-07-14
5812SUPPL2010-07-14
37300SUPPL2010-07-12
37299SUPPL2010-07-12
5811SUPPL2008-08-19
5810SUPPL2008-07-17
37297SUPPL2007-06-04
5809SUPPL2007-06-04
37296SUPPL2006-02-22
5808SUPPL2006-02-22
21751ORIG2005-10-06
28202SUPPL2005-08-16
15840SUPPL2005-08-15
5806SUPPL2005-08-15
37295SUPPL2005-06-10
5807SUPPL2005-06-10
28201SUPPL2004-09-07
28200SUPPL2004-06-23
15839ORIG2004-03-03
5805ORIG2004-02-27