Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021590
Company: JAZZ PHARMS III
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FAZACLO ODT CLOZAPINE 25MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB Yes No
FAZACLO ODT CLOZAPINE 100MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB Yes Yes
FAZACLO ODT CLOZAPINE 50MG TABLET, ORALLY DISINTEGRATING;ORAL Discontinued None No No
FAZACLO ODT CLOZAPINE 12.5MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription None Yes No
FAZACLO ODT CLOZAPINE 150MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB Yes No
FAZACLO ODT CLOZAPINE 200MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/10/2004 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21590_fazaclo_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21590ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021590s000_FazacloTOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/23/2017 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021590s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021590Orig1s030ltr.pdf
04/25/2016 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

09/30/2015 SUPPL-28 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021590s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021590Orig1s028,203479Orig1s009ltr.pdf
09/15/2015 SUPPL-27 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021590s014s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021590Orig1s014,s027ltr.pdf
11/07/2012 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

01/09/2012 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021590s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021590s024ltr.pdf
07/19/2013 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021590s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021590Orig1s021ltr.pdf
12/01/2010 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021590s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021590s018ltr.pdf
09/08/2010 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021590s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021590s017ltr.pdf
07/09/2010 SUPPL-16 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021590s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021590s015,s016ltr.pdf
07/09/2010 SUPPL-15 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021590s015s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021590s015,s016ltr.pdf
09/15/2015 SUPPL-14 REMS-Proposal Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021590s014s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021590Orig1s014,s027ltr.pdf
08/14/2008 SUPPL-13 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021590s013ltr.pdf
07/15/2008 SUPPL-11 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021590s011ltr.pdf
05/30/2007 SUPPL-10 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021590s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021590s010ltr.pdf
02/16/2006 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021590s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021590s009ltr.pdf
08/12/2005 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021590s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021590s008ltr.pdf
06/08/2005 SUPPL-7 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021590s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021590s007ltr.pdf
08/12/2005 SUPPL-3 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021590s003ltr.pdf
09/03/2004 SUPPL-2 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21590s002ltr.pdf
06/17/2004 SUPPL-1 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21590slr001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/23/2017 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021590s030lbl.pdf
09/30/2015 SUPPL-28 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021590s028lbl.pdf
09/15/2015 SUPPL-27 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021590s014s027lbl.pdf
09/15/2015 SUPPL-14 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021590s014s027lbl.pdf
07/19/2013 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021590s021lbl.pdf
01/09/2012 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021590s024lbl.pdf
12/01/2010 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021590s018lbl.pdf
09/08/2010 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021590s017lbl.pdf
07/09/2010 SUPPL-16 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021590s015s016lbl.pdf
07/09/2010 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021590s015s016lbl.pdf
05/30/2007 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021590s010lbl.pdf
05/30/2007 SUPPL-10 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021590s010lbl.pdf
02/16/2006 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021590s009lbl.pdf
08/12/2005 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021590s008lbl.pdf
06/08/2005 SUPPL-7 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021590s007lbl.pdf
02/10/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21590_fazaclo_lbl.pdf

FAZACLO ODT

TABLET, ORALLY DISINTEGRATING;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLOZAPINE CLOZAPINE 25MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 090308 BARR LABS INC
CLOZAPINE CLOZAPINE 25MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 201824 MYLAN PHARMS INC
FAZACLO ODT CLOZAPINE 25MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 021590 JAZZ PHARMS III

TABLET, ORALLY DISINTEGRATING;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLOZAPINE CLOZAPINE 100MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 090308 BARR LABS INC
CLOZAPINE CLOZAPINE 100MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 201824 MYLAN PHARMS INC
FAZACLO ODT CLOZAPINE 100MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 021590 JAZZ PHARMS III

TABLET, ORALLY DISINTEGRATING;ORAL; 150MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLOZAPINE CLOZAPINE 150MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 203039 TEVA PHARMS USA
FAZACLO ODT CLOZAPINE 150MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 021590 JAZZ PHARMS III

TABLET, ORALLY DISINTEGRATING;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CLOZAPINE CLOZAPINE 200MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 203039 TEVA PHARMS USA
FAZACLO ODT CLOZAPINE 200MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 021590 JAZZ PHARMS III

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