Application 212690

Type: NDA
Sponsor: JAZZ PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	XYWAV	CALCIUM;MAGNESIUM;POTASSIUM;SODIUM OXYBATES	SOLUTION;ORAL	0.5MG/ML	Yes	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68727-150	XYWAV	(calcium, magnesium, potassium, and sodium oxybates)	Jazz Pharmaceuticals, Inc.	NDA	Current
68727-150	XYWAV	(calcium, magnesium, potassium, and sodium oxybates)	Jazz Pharmaceuticals, Inc.	NDA	Current
68727-150	XYWAV	(calcium, magnesium, potassium, and sodium oxybates)	Jazz Pharmaceuticals, Inc.	NDA	Current
68727-150	XYWAV	(calcium, magnesium, potassium, and sodium oxybates)	Jazz Pharmaceuticals, Inc.	NDA	Current
68727-150	XYWAV	(calcium, magnesium, potassium, and sodium oxybates)	Jazz Pharmaceuticals, Inc.	NDA	Current
68727-150	XYWAV	(calcium, magnesium, potassium, and sodium oxybates)	Jazz Pharmaceuticals, Inc.	NDA	Current
68727-150	XYWAV	(calcium, magnesium, potassium, and sodium oxybates)	Jazz Pharmaceuticals, Inc.	NDA	Current
68727-150	XYWAV	(calcium, magnesium, potassium, and sodium oxybates)	Jazz Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82976	SUPPL	2025-07-29
82456	SUPPL	2025-05-30
82298	SUPPL	2025-05-23
80245	SUPPL	2024-11-19
78549	SUPPL	2024-05-23
77233	SUPPL	2024-01-17
76530	ORIG	2023-11-08
75672	APPL	2023-10-04
74063	SUPPL	2023-04-26
74062	SUPPL	2023-04-26
73951	SUPPL	2023-04-05
73290	SUPPL	2023-01-25
71951	SUPPL	2022-08-29
71858	SUPPL	2022-08-23
70137	SUPPL	2022-02-10
69544	SUPPL	2021-12-14
68372	SUPPL	2021-08-13
68371	SUPPL	2021-08-13
68368	SUPPL	2021-08-13
67900	SUPPL	2021-06-25
67442	ORIG	2021-05-07
66238	SUPPL	2021-02-17
66237	SUPPL	2021-02-17
66226	SUPPL	2021-02-16
66225	SUPPL	2021-02-16
64004	ORIG	2020-07-22
63994	ORIG	2020-07-22