Application 215422

Type: NDA
Sponsor: SAOL THERAPS RES LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LYVISPAH	BACLOFEN	GRANULE;ORAL	5MG	Yes	No
002	LYVISPAH	BACLOFEN	GRANULE;ORAL	10MG	Yes	No
003	LYVISPAH	BACLOFEN	GRANULE;ORAL	20MG	Yes	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N215422-001	LYVISPAH	BACLOFEN	5MG/PACKET	GRANULE / ORAL	RLD	2021-11-22
N215422-002	LYVISPAH	BACLOFEN	10MG/PACKET	GRANULE / ORAL	RLD	2021-11-22
N215422-003	LYVISPAH	BACLOFEN	20MG/PACKET	GRANULE / ORAL	RLD	2021-11-22

Orange Book patents#

Current patent rows page 1 of 1 · 21 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N215422-001	10792262	2039-07-29	U-3263	Drug product	2021-12-21
N215422-001	11654124	2039-07-29		Drug product	2023-06-14
N215422-001	11931328	2039-07-29		Drug product	2024-04-02
N215422-001	11491125	2041-09-29	U-3488	Drug product	2022-12-05
N215422-001	11491125	2041-09-29	U-3489	Drug product	2022-12-05
N215422-001	11850225	2041-09-29	U-3488	Drug product	2024-01-22
N215422-001	11850225	2041-09-29	U-3489	Drug product	2024-01-22
N215422-002	10792262	2039-07-29	U-3263	Drug product	2021-12-21
N215422-002	11654124	2039-07-29		Drug product	2023-06-14
N215422-002	11931328	2039-07-29		Drug product	2024-04-02
N215422-002	11491125	2041-09-29	U-3488	Drug product	2022-12-05
N215422-002	11491125	2041-09-29	U-3489	Drug product	2022-12-05
N215422-002	11850225	2041-09-29	U-3488	Drug product	2024-01-22
N215422-002	11850225	2041-09-29	U-3489	Drug product	2024-01-22
N215422-003	10792262	2039-07-29	U-3263	Drug product	2021-12-21
N215422-003	11654124	2039-07-29		Drug product	2023-06-14
N215422-003	11931328	2039-07-29		Drug product	2024-04-02
N215422-003	11491125	2041-09-29	U-3488	Drug product	2022-12-05
N215422-003	11491125	2041-09-29	U-3489	Drug product	2022-12-05
N215422-003	11850225	2041-09-29	U-3488	Drug product	2024-01-22
N215422-003	11850225	2041-09-29	U-3489	Drug product	2024-01-22

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.

Product history page 1 of 3 · 102 observed 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	N215422-001	LYVISPAH	5MG/PACKET	GRANULE / ORAL	RLD	2021-11-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215422-002	LYVISPAH	10MG/PACKET	GRANULE / ORAL	RLD	2021-11-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215422-003	LYVISPAH	20MG/PACKET	GRANULE / ORAL	RLD	2021-11-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215422-001	LYVISPAH	5MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215422-002	LYVISPAH	10MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215422-003	LYVISPAH	20MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215422-001	LYVISPAH	5MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215422-002	LYVISPAH	10MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215422-003	LYVISPAH	20MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215422-001	LYVISPAH	5MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215422-002	LYVISPAH	10MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215422-003	LYVISPAH	20MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215422-001	LYVISPAH	5MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215422-002	LYVISPAH	10MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215422-003	LYVISPAH	20MG/PACKET	GRANULES / ORAL	RLD, RS	2021-11-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215422-001	LYVISPAH	5MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215422-002	LYVISPAH	10MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215422-003	LYVISPAH	20MG/PACKET	GRANULES / ORAL	RLD, RS	2021-11-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215422-001	LYVISPAH	5MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215422-002	LYVISPAH	10MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215422-003	LYVISPAH	20MG/PACKET	GRANULES / ORAL	RLD, RS	2021-11-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215422-001	LYVISPAH	5MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215422-002	LYVISPAH	10MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215422-003	LYVISPAH	20MG/PACKET	GRANULES / ORAL	RLD, RS	2021-11-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215422-001	LYVISPAH	5MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215422-002	LYVISPAH	10MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215422-003	LYVISPAH	20MG/PACKET	GRANULES / ORAL	RLD, RS	2021-11-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215422-001	LYVISPAH	5MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215422-002	LYVISPAH	10MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215422-003	LYVISPAH	20MG/PACKET	GRANULES / ORAL	RLD, RS	2021-11-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215422-001	LYVISPAH	5MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215422-002	LYVISPAH	10MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215422-003	LYVISPAH	20MG/PACKET	GRANULES / ORAL	RLD, RS	2021-11-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215422-001	LYVISPAH	5MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215422-002	LYVISPAH	10MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215422-003	LYVISPAH	20MG/PACKET	GRANULES / ORAL	RLD, RS	2021-11-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215422-001	LYVISPAH	5MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215422-002	LYVISPAH	10MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215422-003	LYVISPAH	20MG/PACKET	GRANULES / ORAL	RLD, RS	2021-11-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215422-001	LYVISPAH	5MG/PACKET	GRANULES / ORAL	RLD	2021-11-22	`1e350fbaab3a…`

Observed Orange Book patent history#

Patent history page 1 of 12 · 471 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	N215422-001	10792262	2039-07-29	U-3263	Drug product	2021-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215422-001	11654124	2039-07-29		Drug product	2023-06-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215422-001	11931328	2039-07-29		Drug product	2024-04-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215422-001	11491125	2041-09-29	U-3488	Drug product	2022-12-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215422-001	11491125	2041-09-29	U-3489	Drug product	2022-12-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215422-001	11850225	2041-09-29	U-3488	Drug product	2024-01-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215422-001	11850225	2041-09-29	U-3489	Drug product	2024-01-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215422-002	10792262	2039-07-29	U-3263	Drug product	2021-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215422-002	11654124	2039-07-29		Drug product	2023-06-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215422-002	11931328	2039-07-29		Drug product	2024-04-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215422-002	11491125	2041-09-29	U-3489	Drug product	2022-12-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215422-002	11491125	2041-09-29	U-3488	Drug product	2022-12-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215422-002	11850225	2041-09-29	U-3489	Drug product	2024-01-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215422-002	11850225	2041-09-29	U-3488	Drug product	2024-01-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215422-003	10792262	2039-07-29	U-3263	Drug product	2021-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215422-003	11654124	2039-07-29		Drug product	2023-06-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215422-003	11931328	2039-07-29		Drug product	2024-04-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215422-003	11491125	2041-09-29	U-3489	Drug product	2022-12-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215422-003	11491125	2041-09-29	U-3488	Drug product	2022-12-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215422-003	11850225	2041-09-29	U-3489	Drug product	2024-01-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215422-003	11850225	2041-09-29	U-3488	Drug product	2024-01-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215422-001	10792262	2039-07-29	U-3263	Drug product	2021-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215422-001	11654124	2039-07-29		Drug product	2023-06-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215422-001	11931328	2039-07-29		Drug product	2024-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215422-001	11491125	2041-09-29	U-3488	Drug product	2022-12-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215422-001	11491125	2041-09-29	U-3489	Drug product	2022-12-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215422-001	11850225	2041-09-29	U-3488	Drug product	2024-01-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215422-001	11850225	2041-09-29	U-3489	Drug product	2024-01-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215422-002	10792262	2039-07-29	U-3263	Drug product	2021-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215422-002	11654124	2039-07-29		Drug product	2023-06-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215422-002	11931328	2039-07-29		Drug product	2024-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215422-002	11491125	2041-09-29	U-3489	Drug product	2022-12-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215422-002	11491125	2041-09-29	U-3488	Drug product	2022-12-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215422-002	11850225	2041-09-29	U-3489	Drug product	2024-01-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215422-002	11850225	2041-09-29	U-3488	Drug product	2024-01-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215422-003	10792262	2039-07-29	U-3263	Drug product	2021-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215422-003	11654124	2039-07-29		Drug product	2023-06-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215422-003	11931328	2039-07-29		Drug product	2024-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215422-003	11491125	2041-09-29	U-3489	Drug product	2022-12-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215422-003	11491125	2041-09-29	U-3488	Drug product	2022-12-05	`011fe1cb6892…`

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
LYVISPAH	BACLOFEN	Amneal Pharmaceuticals LLC	f8992a56-9010-4c4b-84d5-ddcc3e2c3317	2023-04-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 215422 application number: NDA215422

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70257-412	Lyvispah	baclofen	Saol Therapeutics Inc	NDA	Current
70257-414	Lyvispah	baclofen	Saol Therapeutics Inc	NDA	Current
70257-416	Lyvispah	baclofen	Saol Therapeutics Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
71662	ORIG	2022-07-29
69398	ORIG	2021-11-23
69397	ORIG	2021-11-23