Application 217788

Type: ANDA
Sponsor: RISING

Application Products#

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

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	Approval date
A217788-001	BACLOFEN	BACLOFEN	10MG	TABLET / ORAL	AB	2024-01-10
A217788-002	BACLOFEN	BACLOFEN	20MG	TABLET / ORAL	AB	2024-01-10
A217788-003	BACLOFEN	BACLOFEN	5MG	TABLET / ORAL	AB	2024-10-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217788-001	AB
A217788-002	AB
A217788-003	AB

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 · 49 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	A217788-001	BACLOFEN	10MG	TABLET / ORAL	AB	2024-01-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217788-002	BACLOFEN	20MG	TABLET / ORAL	AB	2024-01-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217788-003	BACLOFEN	5MG	TABLET / ORAL	AB	2024-10-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217788-001	BACLOFEN	10MG	TABLET / ORAL	AB	2024-01-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217788-002	BACLOFEN	20MG	TABLET / ORAL	AB	2024-01-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217788-003	BACLOFEN	5MG	TABLET / ORAL	AB	2024-10-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217788-001	BACLOFEN	10MG	TABLET / ORAL	AB	2024-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217788-002	BACLOFEN	20MG	TABLET / ORAL	AB	2024-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217788-003	BACLOFEN	5MG	TABLET / ORAL	AB	2024-10-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217788-001	BACLOFEN	10MG	TABLET / ORAL	AB	2024-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217788-002	BACLOFEN	20MG	TABLET / ORAL	AB	2024-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217788-003	BACLOFEN	5MG	TABLET / ORAL	AB	2024-10-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217788-001	BACLOFEN	10MG	TABLET / ORAL	AB	2024-01-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217788-002	BACLOFEN	20MG	TABLET / ORAL	AB	2024-01-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217788-003	BACLOFEN	5MG	TABLET / ORAL	AB	2024-10-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217788-001	BACLOFEN	10MG	TABLET / ORAL	AB	2024-01-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217788-002	BACLOFEN	20MG	TABLET / ORAL	AB	2024-01-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217788-003	BACLOFEN	5MG	TABLET / ORAL	AB	2024-10-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217788-001	BACLOFEN	10MG	TABLET / ORAL	AB	2024-01-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217788-002	BACLOFEN	20MG	TABLET / ORAL	AB	2024-01-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217788-003	BACLOFEN	5MG	TABLET / ORAL	AB	2024-10-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217788-001	BACLOFEN	10MG	TABLET / ORAL	AB	2024-01-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217788-002	BACLOFEN	20MG	TABLET / ORAL	AB	2024-01-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217788-003	BACLOFEN	5MG	TABLET / ORAL	AB	2024-10-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217788-001	BACLOFEN	10MG	TABLET / ORAL	AB	2024-01-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217788-002	BACLOFEN	20MG	TABLET / ORAL	AB	2024-01-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217788-003	BACLOFEN	5MG	TABLET / ORAL	AB	2024-10-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217788-001	BACLOFEN	10MG	TABLET / ORAL	AB	2024-01-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217788-002	BACLOFEN	20MG	TABLET / ORAL	AB	2024-01-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217788-001	BACLOFEN	10MG	TABLET / ORAL	AB	2024-01-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217788-002	BACLOFEN	20MG	TABLET / ORAL	AB	2024-01-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217788-003	BACLOFEN	5MG	TABLET / ORAL	AB	2024-10-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217788-001	BACLOFEN	10MG	TABLET / ORAL	AB	2024-01-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217788-002	BACLOFEN	20MG	TABLET / ORAL	AB	2024-01-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217788-001	BACLOFEN	10MG	TABLET / ORAL	AB	2024-01-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217788-002	BACLOFEN	20MG	TABLET / ORAL	AB	2024-01-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217788-001	BACLOFEN	10MG	TABLET / ORAL	AB	2024-01-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217788-002	BACLOFEN	20MG	TABLET / ORAL	AB	2024-01-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217788-001	BACLOFEN	10MG	TABLET / ORAL	AB	2024-01-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217788-002	BACLOFEN	20MG	TABLET / ORAL	AB	2024-01-10	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 49 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A217788-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217788-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217788-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217788-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217788-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217788-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217788-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217788-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217788-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217788-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217788-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217788-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217788-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217788-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217788-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217788-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217788-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217788-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217788-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217788-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217788-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217788-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217788-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217788-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217788-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217788-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217788-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217788-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217788-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217788-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217788-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217788-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217788-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217788-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217788-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217788-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217788-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217788-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217788-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217788-002	AB	1	`1e350fbaab3a…`

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 7 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	b5fde991-7d12-4083-a3d6-363718f1f6a1	2024-08-16	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Zydus Lifesciences Limited	bb5c6faa-2933-44d1-8706-8302150be734	2024-08-12	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Zydus Pharmaceuticals (USA) Inc.	cfc49176-8d01-4c39-9319-604dd087065c	2024-08-12	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	NuCare Pharmaceuticals,Inc.	b2be2e6c-a247-30f4-e053-2a95a90a6ccb	2024-07-17	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Direct_rx	1bf59c3b-f8eb-972e-e063-6394a90aeccc	2024-06-28	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
BACLOFEN	BACLOFEN	Bryant Ranch Prepack	9834e409-8633-4f99-8ac7-7fa298d01c44	2024-05-30	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
Baclofen	BACLOFEN	Advanced Rx Pharmacy of Tennessee, LLC	19b049cf-56a4-aeaa-e063-6394a90a366d	2024-05-30	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
BACLOFEN	BACLOFEN	Bryant Ranch Prepack	adc072b9-e48b-470d-9eb1-fd7b52c1f122	2024-05-29	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
BACLOFEN	BACLOFEN	TruPharma LLC	68aa591e-ea98-4438-9a4a-4f7e9ea2b285	2024-04-17	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
Baclofen	BACLOFEN	Bryant Ranch Prepack	d24135b3-e247-412f-a10b-ceecbdee3aef	2024-04-02	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Bryant Ranch Prepack	80a4c6f7-4f02-493c-9263-62e1c90404ba	2024-04-02	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
BACLOFEN	BACLOFEN	Rising Pharma Holdings, Inc.	6eb46715-d72b-473f-b984-90024033d4a0	2024-03-01	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
Baclofen	BACLOFEN	Bryant Ranch Prepack	7f27f935-b1fa-4494-9014-7f62c59bb8e3	2024-01-30	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Bryant Ranch Prepack	fc4b99b3-f59f-4e1f-9a8c-123a0c2fbd9f	2024-01-30	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Bryant Ranch Prepack	402a0a2b-95a6-4d22-bedf-826e1f1cd2c3	2024-01-11	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Bryant Ranch Prepack	b4506087-be24-4e76-9fb8-b07805137072	2024-01-10	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Bryant Ranch Prepack	54bea140-c537-44a2-8d1d-bfb20471f4d8	2024-01-10	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Bryant Ranch Prepack	12d57610-8c70-4729-b358-56525613a29d	2024-01-10	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Bryant Ranch Prepack	ff8e9fa8-5f06-4902-b1ac-a7fc09ccddbb	2024-01-09	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Aphena Pharma Solutions - Tennessee, LLC	c582972d-22ef-4326-b37f-adf2ca0b1875	2023-12-21	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.