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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N212690-001	XYWAV	CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL		RLD, RS	2020-07-21

Orange Book patents#

Current patent rows page 1 of 1 · 25 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N212690-001	10195168	2033-01-11		Drug product	2020-08-19
N212690-001	10675258	2033-01-11	U-2938		2020-08-19
N212690-001	11554102	2033-01-11		Drug product	2023-02-08
N212690-001	8591922	2033-01-11		Drug product	2020-08-19
N212690-001	8901173	2033-01-11		Drug product	2020-08-19
N212690-001	9132107	2033-01-11		Drug product	2020-08-19
N212690-001	10213400	2033-03-15	U-2499		2020-08-19
N212690-001	10864181	2033-03-15	U-3017		2021-01-13
N212690-001	11253494	2033-03-15	U-3323		2022-03-15
N212690-001	11253494	2033-03-15	U-3324		2022-03-15
N212690-001	11986446	2033-03-15	U-3017		2024-06-18
N212690-001	11986446	2033-03-15	U-3324		2024-06-18
N212690-001	8772306	2033-03-15	U-1532		2020-08-19
N212690-001	8772306	2033-03-15	U-3198		2020-08-19
N212690-001	9050302	2033-03-15	U-1532		2020-08-19
N212690-001	9486426	2033-03-15	U-1532		2020-08-19
N212690-001	10213400*PED	2033-09-15		Pediatric extension
N212690-001	10864181*PED	2033-09-15		Pediatric extension
N212690-001	11253494*PED	2033-09-15		Pediatric extension
N212690-001	8772306*PED	2033-09-15		Pediatric extension
N212690-001	9050302*PED	2033-09-15		Pediatric extension
N212690-001	9486426*PED	2033-09-15		Pediatric extension
N212690-001	11426373	2037-09-19	U-3432		2022-09-27
N212690-001	12138233	2041-02-22	U-4044		2024-12-11
N212690-001	12582622	2041-02-22	U-4044		2026-04-13

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 3 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N212690-001	ODE-361	2027-07-21
N212690-001	PED	2028-01-21
N212690-001	ODE-369	2028-08-12

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N212690-001	XYWAV	0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION / ORAL	RLD, RS	2020-07-21	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 19 · 757 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N212690-001	10195168	2033-01-11		Drug product	2020-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212690-001	10675258	2033-01-11	U-2938		2020-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212690-001	11554102	2033-01-11		Drug product	2023-02-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212690-001	8591922	2033-01-11		Drug product	2020-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212690-001	8901173	2033-01-11		Drug product	2020-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212690-001	9132107	2033-01-11		Drug product	2020-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212690-001	10213400	2033-03-15	U-2499		2020-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212690-001	10864181	2033-03-15	U-3017		2021-01-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212690-001	11253494	2033-03-15	U-3323		2022-03-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212690-001	11253494	2033-03-15	U-3324		2022-03-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212690-001	11986446	2033-03-15	U-3017		2024-06-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212690-001	11986446	2033-03-15	U-3324		2024-06-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212690-001	8772306	2033-03-15	U-3198		2020-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212690-001	8772306	2033-03-15	U-1532		2020-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212690-001	9050302	2033-03-15	U-1532		2020-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212690-001	9486426	2033-03-15	U-1532		2020-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212690-001	10213400*PED	2033-09-15		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212690-001	10864181*PED	2033-09-15		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212690-001	11253494*PED	2033-09-15		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212690-001	8772306*PED	2033-09-15		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212690-001	9050302*PED	2033-09-15		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212690-001	9486426*PED	2033-09-15		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212690-001	11426373	2037-09-19	U-3432		2022-09-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212690-001	12138233	2041-02-22	U-4044		2024-12-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212690-001	12582622	2041-02-22	U-4044		2026-04-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212690-001	10195168	2033-01-11		Drug product	2020-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212690-001	10675258	2033-01-11	U-2938		2020-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212690-001	11554102	2033-01-11		Drug product	2023-02-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212690-001	8591922	2033-01-11		Drug product	2020-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212690-001	8901173	2033-01-11		Drug product	2020-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212690-001	9132107	2033-01-11		Drug product	2020-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212690-001	10213400	2033-03-15	U-2499		2020-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212690-001	10864181	2033-03-15	U-3017		2021-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212690-001	11253494	2033-03-15	U-3323		2022-03-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212690-001	11253494	2033-03-15	U-3324		2022-03-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212690-001	11986446	2033-03-15	U-3017		2024-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212690-001	11986446	2033-03-15	U-3324		2024-06-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212690-001	8772306	2033-03-15	U-3198		2020-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212690-001	8772306	2033-03-15	U-1532		2020-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212690-001	9050302	2033-03-15	U-1532		2020-08-19	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 127 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N212690-001	ODE-361	2027-07-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212690-001	PED	2028-01-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212690-001	ODE-369	2028-08-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212690-001	ODE-361	2027-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212690-001	PED	2028-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212690-001	ODE-369	2028-08-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212690-001	ODE-361	2027-07-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212690-001	PED	2028-01-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212690-001	ODE-369	2028-08-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212690-001	ODE-361	2027-07-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212690-001	PED	2028-01-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212690-001	ODE-369	2028-08-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212690-001	ODE-361	2027-07-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212690-001	PED	2028-01-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212690-001	ODE-369	2028-08-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212690-001	ODE-361	2027-07-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212690-001	PED	2028-01-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212690-001	ODE-369	2028-08-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212690-001	I-870	2024-08-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212690-001	ODE-361	2027-07-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212690-001	PED	2028-01-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212690-001	ODE-369	2028-08-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212690-001	I-870	2024-08-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212690-001	ODE-361	2027-07-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212690-001	PED	2028-01-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212690-001	ODE-369	2028-08-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212690-001	I-870	2024-08-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212690-001	ODE-361	2027-07-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212690-001	PED	2028-01-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212690-001	ODE-369	2028-08-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212690-001	I-870	2024-08-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212690-001	ODE-361	2027-07-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212690-001	PED	2028-01-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212690-001	ODE-369	2028-08-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212690-001	I-870	2024-08-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212690-001	ODE-361	2027-07-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212690-001	PED	2028-01-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212690-001	ODE-369	2028-08-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212690-001	I-870	2024-08-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212690-001	ODE-361	2027-07-21	`79d66fd596c7…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
XYWAV	CALCIUM, MAGNESIUM, POTASSIUM, AND SODIUM OXYBATES	Jazz Pharmaceuticals, Inc.	1e0ae43a-037f-42af-8e23-a0e51d75abe8	2025-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 212690 application number: NDA212690 ndc (product): 68727-150

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

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