Application 020075

Type: NDA
Sponsor: SAOL THERAPS RES LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LIORESAL	BACLOFEN	INJECTABLE;INTRATHECAL	0.5MG/ML	Yes	Yes
002	LIORESAL	BACLOFEN	INJECTABLE;INTRATHECAL	2MG/ML	Yes	Yes
003	LIORESAL	BACLOFEN	INJECTABLE;INTRATHECAL	0.05MG/ML	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	TE codes	RLD / RS	Approval date
N020075-001	LIORESAL	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17
N020075-002	LIORESAL	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17
N020075-003	LIORESAL	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1996-11-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N020075-001	AP
N020075-002	AP
N020075-003	AP

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020075-001	LIORESAL	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020075-002	LIORESAL	2MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020075-003	LIORESAL	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1996-11-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020075-001	LIORESAL	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020075-002	LIORESAL	2MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020075-003	LIORESAL	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1996-11-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020075-001	LIORESAL	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020075-002	LIORESAL	2MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020075-003	LIORESAL	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1996-11-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020075-001	LIORESAL	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020075-002	LIORESAL	2MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020075-003	LIORESAL	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1996-11-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020075-001	LIORESAL	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020075-002	LIORESAL	2MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020075-003	LIORESAL	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1996-11-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020075-001	LIORESAL	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020075-002	LIORESAL	2MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020075-003	LIORESAL	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1996-11-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020075-001	LIORESAL	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020075-002	LIORESAL	2MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020075-003	LIORESAL	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1996-11-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020075-001	LIORESAL	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020075-002	LIORESAL	2MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020075-003	LIORESAL	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1996-11-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020075-001	LIORESAL	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020075-002	LIORESAL	2MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020075-003	LIORESAL	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1996-11-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020075-001	LIORESAL	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020075-002	LIORESAL	2MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020075-003	LIORESAL	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1996-11-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020075-001	LIORESAL	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020075-002	LIORESAL	2MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020075-003	LIORESAL	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1996-11-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020075-001	LIORESAL	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020075-002	LIORESAL	2MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020075-003	LIORESAL	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1996-11-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020075-001	LIORESAL	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020075-002	LIORESAL	2MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020075-003	LIORESAL	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1996-11-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020075-001	LIORESAL	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	1992-06-17	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020075-002	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020075-003	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020075-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020075-002	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020075-003	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020075-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020075-002	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020075-003	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020075-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020075-002	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020075-003	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020075-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020075-002	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020075-003	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020075-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020075-002	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020075-003	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020075-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020075-002	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020075-003	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020075-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020075-002	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020075-003	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020075-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020075-002	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020075-003	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020075-001	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020075-002	AP	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020075-003	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020075-001	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020075-002	AP	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020075-003	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020075-001	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020075-002	AP	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020075-003	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020075-001	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020075-002	AP	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020075-003	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020075-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020075-002	AP	1	`3f01610625f2…`

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
Lioresal (baclofen)	BACLOFEN	Amneal Pharmaceuticals LLC	6f3bdcc0-ffc8-4911-8c35-958c8103a2c5	2022-12-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020075 application number: NDA020075 ndc (product): 70121-2502 ndc (product): 70121-2504 ndc (product): 70121-2503 ndc (product): 70121-2501

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
58281-560	Lioresal	baclofen	Medtronic Neuromodulation	NDA	Current
58281-561	Lioresal	baclofen	Medtronic Neuromodulation	NDA	Current
58281-562	Lioresal	baclofen	Medtronic Neuromodulation	NDA	Current
58281-563	Lioresal	baclofen	Medtronic Neuromodulation	NDA	Current
70121-2501	Lioresal (baclofen)	baclofen	Amneal Pharmaceuticals LLC	NDA	Current
70121-2502	Lioresal (baclofen)	baclofen	Amneal Pharmaceuticals LLC	NDA	Current
70121-2503	Lioresal (baclofen)	baclofen	Amneal Pharmaceuticals LLC	NDA	Current
70121-2504	Lioresal (baclofen)	baclofen	Amneal Pharmaceuticals LLC	NDA	Current
70257-560	Lioresal (baclofen)	baclofen	Saol Therapeutics Inc.	NDA	Current
70257-560	Lioresal (baclofen)	baclofen	Saol Therapeutics Inc.	NDA	Current
70257-560	Lioresal (baclofen)	baclofen	Saol Therapeutics Inc.	NDA	Current
70257-561	Lioresal (baclofen)	baclofen	Saol Therapeutics Inc.	NDA	Current
70257-561	Lioresal (baclofen)	baclofen	Saol Therapeutics Inc.	NDA	Current
70257-561	Lioresal (baclofen)	baclofen	Saol Therapeutics Inc.	NDA	Current
70257-562	Lioresal (baclofen)	baclofen	Saol Therapeutics Inc.	NDA	Current
70257-562	Lioresal (baclofen)	baclofen	Saol Therapeutics Inc.	NDA	Current
70257-562	Lioresal (baclofen)	baclofen	Saol Therapeutics Inc.	NDA	Current
70257-563	Lioresal (baclofen)	baclofen	Saol Therapeutics Inc.	NDA	Current
70257-563	Lioresal (baclofen)	baclofen	Saol Therapeutics Inc.	NDA	Current
70257-563	Lioresal (baclofen)	baclofen	Saol Therapeutics Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
70699	SUPPL	2022-04-05
70615	SUPPL	2022-03-28
57311	SUPPL	2019-01-22
57235	SUPPL	2019-01-17
45597	SUPPL	2016-10-06
45461	SUPPL	2016-10-04
1990	SUPPL	2014-11-21
34238	SUPPL	2013-11-22
21110	SUPPL	2013-11-20
34237	SUPPL	2013-03-08
12180	SUPPL	2011-11-16
1989	SUPPL	2011-11-16
34236	SUPPL	2011-03-29
21109	SUPPL	2011-03-29
1988	SUPPL	2003-05-30
21108	SUPPL	2003-01-17
1987	SUPPL	2002-11-20
21107	SUPPL	2002-03-06
1986	SUPPL	2002-03-06