Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021196
Company: JAZZ PHARMS
Company: JAZZ PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| XYREM | SODIUM OXYBATE | 0.5GM/ML | SOLUTION;ORAL | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 07/17/2002 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21196lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21196ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-196_Xyrem.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/11/2021 | SUPPL-35 | REMS - MODIFIED - D-N-A |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212690Orig1s001,%20s002;%20021196Orig1s035ltr.pdf |
| 07/21/2020 | SUPPL-34 | REMS - MODIFIED - D-N-A |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021196s033s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021196Orig1s033,s034ltr.pdf | |
| 07/21/2020 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021196s033s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021196Orig1s033,s034ltr.pdf | |
| 09/25/2020 | SUPPL-32 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021196s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021196Orig1s032ltr.pdf | |
| 05/09/2019 | SUPPL-31 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021196Orig1s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021196Orig1s031ltr.pdf | |
| 10/26/2018 | SUPPL-30 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021196s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021196Orig1s30Ltr.pdf | |
| 11/16/2017 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021196s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021196Orig1s028ltr.pdf | |
| 01/26/2017 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021196s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021196Orig1s027ltr.pdf | |
| 04/19/2017 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021196s026lbl.pdf | |
| 06/23/2016 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/15/2015 | SUPPL-23 | Labeling-Package Insert |
Label
Letter (PDF) |
https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=345 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021196Orig1s023ltr.pdf | |
| 08/17/2015 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/23/2015 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/11/2014 | SUPPL-19 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021196Orig1s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021196Orig1s019ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/021196Orig1s019.pdf | |
| 12/20/2013 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/27/2015 | SUPPL-15 | Labeling, REMS-Proposal |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021196Orig1s015ltr.pdf |
| 12/17/2012 | SUPPL-13 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021196s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021196Orig1s013ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021196Orig1s013.pdf | |
| 11/13/2006 | SUPPL-12 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021196s012LTR.pdf |
| 06/30/2006 | SUPPL-9 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021196s009ltr.pdf |
| 09/16/2005 | SUPPL-7 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021196s007ltr.pdf |
| 11/18/2005 | SUPPL-5 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021196s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021196s005ltr.pdf | |
| 11/04/2003 | SUPPL-1 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21196slr001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/25/2020 | SUPPL-32 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021196s032lbl.pdf | |
| 07/21/2020 | SUPPL-34 | REMS - MODIFIED - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021196s033s034lbl.pdf | |
| 07/21/2020 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021196s033s034lbl.pdf | |
| 05/09/2019 | SUPPL-31 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021196Orig1s031lbl.pdf | |
| 10/26/2018 | SUPPL-30 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021196s030lbl.pdf | |
| 11/16/2017 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021196s028lbl.pdf | |
| 04/19/2017 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021196s026lbl.pdf | |
| 01/26/2017 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021196s027lbl.pdf | |
| 07/15/2015 | SUPPL-23 | Labeling-Package Insert | https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=345 | ||
| 04/11/2014 | SUPPL-19 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021196Orig1s019lbl.pdf | |
| 12/17/2012 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021196s013lbl.pdf | |
| 11/18/2005 | SUPPL-5 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021196s005lbl.pdf | |
| 07/17/2002 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21196lbl.pdf |
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English