Application 216309

Type: ANDA
Sponsor: HERITAGE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BACLOFEN	BACLOFEN	INJECTABLE;INTRATHECAL	0.5MG/ML	No	No
002	BACLOFEN	BACLOFEN	INJECTABLE;INTRATHECAL	2MG/ML	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A216309-001	BACLOFEN	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL			2023-08-10
A216309-002	BACLOFEN	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL			2023-08-10

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 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A216309-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL		2023-08-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216309-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL		2023-08-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216309-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL		2023-08-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216309-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL		2023-08-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216309-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL		2023-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216309-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL		2023-08-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216309-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL		2023-08-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216309-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL		2023-08-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216309-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL		2023-08-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216309-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL		2023-08-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216309-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL		2023-08-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216309-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL		2023-08-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216309-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL		2023-08-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216309-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL		2023-08-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216309-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL		2023-08-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216309-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL		2023-08-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216309-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL		2023-08-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216309-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL		2023-08-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216309-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL		2023-08-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216309-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL		2023-08-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216309-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL		2023-08-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216309-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL		2023-08-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216309-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL		2023-08-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216309-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL		2023-08-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216309-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL		2023-08-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216309-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL		2023-08-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216309-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL		2023-08-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216309-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL		2023-08-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216309-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL		2023-08-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216309-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL		2023-08-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216309-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL		2023-08-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216309-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL		2023-08-10	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216309-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL		2023-08-10	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216309-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL		2023-08-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216309-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL		2023-08-10	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216309-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL		2023-08-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216309-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2023-08-10	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A216309-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2023-08-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216309-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2023-08-10	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216309-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2023-08-10	`a72a2bbeb626…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-12-20 04:57 UTC	2023-12	A216309-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A216309-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216309-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216309-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216309-001	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216309-002	AP	1	`9b2671bbb829…`

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 8 of 9 · 168 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Baclofen	BACLOFEN	A-S Medication Solutions	e163e7dc-45a5-43c2-b13d-a4453f2c360c	2023-12-05	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	A-S Medication Solutions	081d478a-2f3f-456e-bcca-00487589da6f	2023-12-05	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen (Intrathecal)	BACLOFEN	MAIA Pharmaceuticals, Inc.	11ba5575-a856-414a-89f8-17f3a01de55b	2023-11-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BACLOFEN
Baclofen	BACLOFEN	Bryant Ranch Prepack	58816b46-28a5-48e2-b89d-98df65939386	2023-10-20	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Bryant Ranch Prepack	9110b1cb-8604-4824-9337-84b08d41dd3c	2023-10-20	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Bryant Ranch Prepack	f9cf294a-85d1-4321-af68-4279b20c4b71	2023-10-19	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Bryant Ranch Prepack	fded79a4-c354-448d-96dd-6dc69c46a013	2023-10-19	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Bryant Ranch Prepack	2cd15814-5f70-4c65-9f43-367495486ecd	2023-10-18	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	TRUPHARMA, LLC	f8ec79c6-da65-4fb6-b6bd-45df0d2a52c7	2023-10-18	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Bryant Ranch Prepack	7ed13ef7-329e-40cb-b9b1-31a4bf32ac98	2023-08-29	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
BACLOFEN	BACLOFEN	Bryant Ranch Prepack	96f9caa3-0d36-4d99-8c6f-0da5b0d03527	2023-08-11	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
BACLOFEN	BACLOFEN	Slayback Pharma LLC	9fad5ffc-afae-4c92-a672-ee636df45bc5	2023-06-16	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
Baclofen	BACLOFEN	Unichem Pharmaceuticals (USA), Inc.	b9199878-3fb4-46dc-adbb-b3d9dc3852d4	2023-06-08	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
BACLOFEN	BACLOFEN	NCS HealthCare of KY, LLC dba Vangard Labs	2927228a-7a3e-4e1d-ab5f-4407b00f6899	2023-05-31	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
LYVISPAH	BACLOFEN	Amneal Pharmaceuticals LLC	f8992a56-9010-4c4b-84d5-ddcc3e2c3317	2023-04-23	Warnings, Adverse reactions	Name fallback generic name: BACLOFEN
Baclofen	BACLOFEN	MAlA Pharmaceuticals, Inc.	e05080ef-53d9-4060-aaa4-86a6935467de	2023-03-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	MAlA Pharmaceuticals, Inc.	dfa6148c-693c-45f1-89be-0e77d39f313e	2023-01-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Lioresal (baclofen)	BACLOFEN	Amneal Pharmaceuticals LLC	6f3bdcc0-ffc8-4911-8c35-958c8103a2c5	2022-12-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BACLOFEN
Baclofen	BACLOFEN	Aphena Pharma Solutions - Tennessee, LLC	edef7819-875f-4855-8f1f-32407f82e9dc	2022-09-08	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Proficient Rx LP	b65d3089-0412-487f-a1b4-66f0bc6f398e	2022-03-01	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN

Reported adverse events (FAERS/openFDA)#

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