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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 212690
Company: JAZZ

Medication Guide

REMS

Products on NDA 212690

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
XYWAV	CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 212690

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/21/2020	ORIG-1	Approval	Type 2 - New Active Ingredient	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212690s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212690Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/212690Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/28/2025	SUPPL-19	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/021196Orig1s048,212690Orig1s019ltr.pdf
05/21/2025	SUPPL-17	REMS - MODIFIED - D-N-A	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021196Orig1s047,212690Orig1s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/021196Orig1s047;212690Orig1s017ltr.pdf
11/18/2024	SUPPL-16	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021196Orig1s046, 212690Orig1s16ltr.pdf
05/22/2024	SUPPL-15	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021196Orig1s044, 212690Orig1s015ltr.pdf
01/16/2024	SUPPL-12	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/212690Orig1s012, 021196Orig1s043ltr.pdf
04/04/2023	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212690s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/212690Orig1s011ltr.pdf
08/22/2022	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212690s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212690Orig1s010ltr.pdf
02/09/2022	SUPPL-9	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212690Orig1s009, 021196Orig1s039ltr.pdf
12/09/2021	SUPPL-8	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212690Orig1s008; 21196Orig1s038ltr.pdf
08/12/2021	SUPPL-6	Efficacy-New Indication	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021196s036,212690s001s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212690Orig1s006,021196Orig1s036ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/212690Orig1s006.pdf
06/23/2021	SUPPL-5	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212690Orig1s005ltr.pdf
02/11/2021	SUPPL-2	REMS - MODIFIED - D-N-A	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021196s035,212690s001s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212690Orig1s001, s002; 021196Orig1s035ltr.pdf
02/11/2021	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021196s035,212690s001s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212690Orig1s001, s002; 021196Orig1s035ltr.pdf

Labels for NDA 212690

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/21/2025	SUPPL-17	REMS - MODIFIED - D-N-A	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021196Orig1s047,212690Orig1s017lbl.pdf
04/04/2023	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212690s011lbl.pdf
08/22/2022	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212690s010lbl.pdf
08/12/2021	SUPPL-6	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021196s036,212690s001s006lbl.pdf
02/11/2021	SUPPL-2	REMS - MODIFIED - D-N-A	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021196s035,212690s001s002lbl.pdf
02/11/2021	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021196s035,212690s001s002lbl.pdf
07/21/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212690s000lbl.pdf

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