Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021590
Company: JAZZ
Company: JAZZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| FAZACLO ODT | CLOZAPINE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING;ORAL | Discontinued | None | Yes | No |
| FAZACLO ODT | CLOZAPINE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING;ORAL | Discontinued | None | Yes | No |
| FAZACLO ODT | CLOZAPINE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING;ORAL | Discontinued | None | No | No |
| FAZACLO ODT | CLOZAPINE | 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING;ORAL | Discontinued | None | Yes | No |
| FAZACLO ODT | CLOZAPINE | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING;ORAL | Discontinued | None | Yes | No |
| FAZACLO ODT | CLOZAPINE | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|
| 04/14/2020 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021590s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021590Orig1s032ltr.pdf | |
| 01/16/2019 | SUPPL-31 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021590Orig1s031ltr.pdf |
| 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-Container/Carton Labels, Labeling-Package Insert |
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 |
|---|---|---|---|---|---|
| 04/14/2020 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021590s032lbl.pdf | |
| 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-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021590s010lbl.pdf | |
| 05/30/2007 | SUPPL-10 | Labeling-Package Insert | 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 |