Application 022462

Type: NDA
Sponsor: PIRAMAL CRITICAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GABLOFEN	BACLOFEN	INJECTABLE;INTRATHECAL	0.05MG/ML	No	No
002	GABLOFEN	BACLOFEN	INJECTABLE;INTRATHECAL	0.5MG/ML	No	No
003	GABLOFEN	BACLOFEN	INJECTABLE;INTRATHECAL	2MG/ML	No	No
004	GABLOFEN	BACLOFEN	INJECTABLE;INTRATHECAL	1MG/ML	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022462-001	GABLOFEN	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19
N022462-002	GABLOFEN	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19
N022462-003	GABLOFEN	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19
N022462-004	GABLOFEN	BACLOFEN	1MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2012-06-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N022462-001	AP
N022462-002	AP
N022462-003	AP
N022462-004	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 5 · 168 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
2026-08-18 06:07:40	2026-07	N022462-001	GABLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022462-002	GABLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022462-003	GABLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022462-004	GABLOFEN	1MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2012-06-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022462-001	GABLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022462-002	GABLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022462-003	GABLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022462-004	GABLOFEN	1MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2012-06-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022462-001	GABLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022462-002	GABLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022462-003	GABLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022462-004	GABLOFEN	1MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2012-06-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022462-001	GABLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022462-002	GABLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022462-003	GABLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022462-004	GABLOFEN	1MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2012-06-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022462-001	GABLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022462-002	GABLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022462-003	GABLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022462-004	GABLOFEN	1MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2012-06-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022462-001	GABLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022462-002	GABLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022462-003	GABLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022462-004	GABLOFEN	1MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2012-06-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022462-001	GABLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022462-002	GABLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022462-003	GABLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022462-004	GABLOFEN	1MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2012-06-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022462-001	GABLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022462-002	GABLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022462-003	GABLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022462-004	GABLOFEN	1MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2012-06-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022462-001	GABLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022462-002	GABLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022462-003	GABLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022462-004	GABLOFEN	1MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2012-06-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022462-001	GABLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022462-002	GABLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022462-003	GABLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2010-11-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022462-004	GABLOFEN	1MG/ML	INJECTABLE / INTRATHECAL	AP	RLD, RS	2012-06-22	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N022462-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022462-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022462-003	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022462-004	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022462-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022462-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022462-003	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022462-004	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022462-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022462-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022462-003	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022462-004	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022462-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022462-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022462-003	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022462-004	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022462-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022462-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022462-003	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022462-004	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022462-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022462-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022462-003	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022462-004	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022462-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022462-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022462-003	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022462-004	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022462-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022462-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022462-003	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022462-004	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022462-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022462-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022462-003	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022462-004	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022462-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022462-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022462-003	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022462-004	AP	1	`d8e5a09893c0…`

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
Gablofen	BACLOFEN INJECTION	Piramal Critical Care Inc	00d3e846-dd92-448d-9ab8-6a07be823cc1	2026-05-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022462 application number: NDA022462 ndc (product): 66794-155 ndc (product): 66794-157 ndc (product): 66794-151 ndc (product): 66794-156

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 34 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45945-156	Gablofen	baclofen	Mallinckrodt Inc (Brand Pharmaceuticals)	NDA	Current
45945-157	Gablofen	baclofen	Mallinckrodt Inc (Brand Pharmaceuticals)	NDA	Current
66794-151	Gablofen	Baclofen Injection	Piramal Critical Care Inc	NDA	Current
66794-151	Gablofen	Baclofen Injection	Piramal Critical Care Inc	NDA	Current
66794-151	Gablofen	Baclofen Injection	Piramal Critical Care Inc	NDA	Current
66794-151	Gablofen	Baclofen Injection	Piramal Critical Care Inc	NDA	Current
66794-151	Gablofen	Baclofen Injection	Piramal Critical Care Inc	NDA	Current
66794-151	Gablofen	Baclofen Injection	Piramal Critical Care Inc	NDA	Current
66794-151	Gablofen	Baclofen Injection	Piramal Critical Care Inc	NDA	Current
66794-151	Gablofen	Baclofen Injection	Piramal Critical Care Inc	NDA	Current
66794-155	Gablofen	Baclofen Injection	Piramal Critical Care Inc	NDA	Current
66794-155	Gablofen	Baclofen Injection	Piramal Critical Care Inc	NDA	Current
66794-155	Gablofen	Baclofen Injection	Piramal Critical Care Inc	NDA	Current
66794-155	Gablofen	Baclofen Injection	Piramal Critical Care Inc	NDA	Current
66794-155	Gablofen	Baclofen Injection	Piramal Critical Care Inc	NDA	Current
66794-155	Gablofen	Baclofen Injection	Piramal Critical Care Inc	NDA	Current
66794-155	Gablofen	Baclofen Injection	Piramal Critical Care Inc	NDA	Current
66794-155	Gablofen	Baclofen Injection	Piramal Critical Care Inc	NDA	Current
66794-156	Gablofen	Baclofen Injection	Piramal Critical Care Inc	NDA	Current
66794-156	Gablofen	Baclofen Injection	Piramal Critical Care Inc	NDA	Current
66794-156	Gablofen	Baclofen Injection	Piramal Critical Care Inc	NDA	Current
66794-156	Gablofen	Baclofen Injection	Piramal Critical Care Inc	NDA	Current
66794-156	Gablofen	Baclofen Injection	Piramal Critical Care Inc	NDA	Current
66794-156	Gablofen	Baclofen Injection	Piramal Critical Care Inc	NDA	Current
66794-156	Gablofen	Baclofen Injection	Piramal Critical Care Inc	NDA	Current
66794-156	Gablofen	Baclofen Injection	Piramal Critical Care Inc	NDA	Current
66794-157	Gablofen	Baclofen Injection	Piramal Critical Care Inc	NDA	Current
66794-157	Gablofen	Baclofen Injection	Piramal Critical Care Inc	NDA	Current
66794-157	Gablofen	Baclofen Injection	Piramal Critical Care Inc	NDA	Current
66794-157	Gablofen	Baclofen Injection	Piramal Critical Care Inc	NDA	Current
66794-157	Gablofen	Baclofen Injection	Piramal Critical Care Inc	NDA	Current
66794-157	Gablofen	Baclofen Injection	Piramal Critical Care Inc	NDA	Current
66794-157	Gablofen	Baclofen Injection	Piramal Critical Care Inc	NDA	Current
66794-157	Gablofen	Baclofen Injection	Piramal Critical Care Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
73671	SUPPL	2023-03-03
71190	SUPPL	2022-06-01
71185	SUPPL	2022-06-01
67118	SUPPL	2021-04-20
61423	SUPPL	2019-12-23
61410	SUPPL	2019-12-23
57402	SUPPL	2019-02-01
38733	SUPPL	2015-02-12
7418	SUPPL	2015-02-12
24314	ORIG	2011-03-07
22027	ORIG	2011-03-07
29750	ORIG	2010-11-29
17604	ORIG	2010-11-26