Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021196
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
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
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

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 HIKMA
XYREM SODIUM OXYBATE 500MG/ML SOLUTION;ORAL Prescription Yes AA 021196 JAZZ PHARMS

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