Drugs@FDA: FDA Approved Drug Products
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 | 500MG/ML | SOLUTION;ORAL | Prescription | AA | 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 |
---|---|---|---|---|---|
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) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021196s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021196Orig1s013ltr.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 |
---|---|---|---|---|---|
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 |
XYREM
SOLUTION;ORAL; 500MG/ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
SODIUM OXYBATE | SODIUM OXYBATE | 500MG/ML | SOLUTION;ORAL | Prescription | No | AA | 202090 | WEST-WARD PHARMS INT |
XYREM | SODIUM OXYBATE | 500MG/ML | SOLUTION;ORAL | Prescription | Yes | AA | 021196 | JAZZ PHARMS |
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