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 3 of 9 · 168 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Baclofen	BACLOFEN	Bryant Ranch Prepack	80b0a41e-2cad-4e14-9605-0cd35f9991e9	2026-02-05	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
BACLOFEN	BACLOFEN	Bryant Ranch Prepack	7df6e691-f1d5-441c-b5bb-a3867983e09f	2026-02-05	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
Baclofen	BACLOFEN	Preferred Pharmaceuticals, Inc.	58416ceb-994f-4571-afbd-c2171823f528	2026-01-26	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
BACLOFEN	BACLOFEN	Advagen Pharma Limited	04dac0f6-cc6c-4959-9bca-a6e4a99690f3	2026-01-23	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
Baclofen	BACLOFEN	Preferred Pharmaceuticals Inc.	69d0027a-cb46-4754-9225-071ec1ce4b37	2026-01-21	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	A-S Medication Solutions	975fda6d-d929-482b-8be7-60849026dbdd	2026-01-20	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Bryant Ranch Prepack	808113db-c5c2-404c-ab5f-62b991641cfe	2026-01-12	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Major Pharmaceuticals	ae732bdc-5178-4565-8219-d1787a5211a6	2026-01-09	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Palmetto Pharmaceuticals Inc.	2422746c-afec-ad30-e063-6394a90a0403	2025-12-31	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Northwind Health Company, LLC	06bcfb08-2ada-f803-e063-6394a90a826b	2025-12-26	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
BACLOFEN	BACLOFEN	Advanced Rx of Tennessee, LLC	459ec5f5-4f99-e917-e063-6294a90a23cd	2025-12-18	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
Baclofen	BACLOFEN	Wilshire Pharmaceuticals, Inc.	4585aafe-0af8-4786-a419-6a7e76671ca2	2025-12-16	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
FLEQSUVY	BACLOFEN	Azurity Pharmaceuticals, Inc.	9076d6ce-bbc2-4a9f-9cb9-2de1b675b9aa	2025-12-16	Warnings, Adverse reactions	Name fallback generic name: BACLOFEN
Baclofen	BACLOFEN	PHOENIX RX LLC	45c6d45d-95d5-21b8-e063-6294a90a7955	2025-12-12	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Upsher-Smith Laboratories, LLC	b2747a9d-5fca-4657-9e4b-4112607f30d8	2025-12-11	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
BACLOFEN	BACLOFEN	Advagen Pharma Limited	d63af5f0-c275-480b-89b5-6cf1ad55ab63	2025-12-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
BACLOFEN	BACLOFEN	SOLA Pharmaceuticals, LLC	7b308b35-8c08-458d-860e-c78d057e8260	2025-12-08	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
Baclofen	BACLOFEN	ANI Pharmaceuticals, Inc.	c73ed3af-8e8a-4a18-90fc-a0f2dcc641d0	2025-12-04	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
BACLOFEN	BACLOFEN	Proficient Rx LP	0680301a-1649-46c4-b74e-ab03967945d0	2025-12-01	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
BACLOFEN	BACLOFEN	Aurobindo Pharma Limited	f4e8cbc5-b1f2-4331-a267-d5bd90bcde8a	2025-11-24	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.