Application 077971

Type: ANDA
Sponsor: IMPAX LABS

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	Approval date
A077971-001	BACLOFEN	BACLOFEN	10MG	TABLET / ORAL	2007-10-26
A077971-002	BACLOFEN	BACLOFEN	20MG	TABLET / ORAL	2007-10-26
A077971-003	BACLOFEN	BACLOFEN	5MG	TABLET / ORAL	2021-07-07

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 · 121 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077971-001	BACLOFEN	10MG	TABLET / ORAL	2007-10-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077971-002	BACLOFEN	20MG	TABLET / ORAL	2007-10-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077971-003	BACLOFEN	5MG	TABLET / ORAL	2021-07-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077971-001	BACLOFEN	10MG	TABLET / ORAL	2007-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077971-002	BACLOFEN	20MG	TABLET / ORAL	2007-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077971-003	BACLOFEN	5MG	TABLET / ORAL	2021-07-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077971-001	BACLOFEN	10MG	TABLET / ORAL	2007-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077971-002	BACLOFEN	20MG	TABLET / ORAL	2007-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077971-003	BACLOFEN	5MG	TABLET / ORAL	2021-07-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077971-001	BACLOFEN	10MG	TABLET / ORAL	2007-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077971-002	BACLOFEN	20MG	TABLET / ORAL	2007-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077971-003	BACLOFEN	5MG	TABLET / ORAL	2021-07-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077971-001	BACLOFEN	10MG	TABLET / ORAL	2007-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077971-002	BACLOFEN	20MG	TABLET / ORAL	2007-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077971-003	BACLOFEN	5MG	TABLET / ORAL	2021-07-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077971-001	BACLOFEN	10MG	TABLET / ORAL	2007-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077971-002	BACLOFEN	20MG	TABLET / ORAL	2007-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077971-003	BACLOFEN	5MG	TABLET / ORAL	2021-07-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077971-001	BACLOFEN	10MG	TABLET / ORAL	2007-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077971-002	BACLOFEN	20MG	TABLET / ORAL	2007-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077971-003	BACLOFEN	5MG	TABLET / ORAL	2021-07-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077971-001	BACLOFEN	10MG	TABLET / ORAL	2007-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077971-002	BACLOFEN	20MG	TABLET / ORAL	2007-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077971-003	BACLOFEN	5MG	TABLET / ORAL	2021-07-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077971-001	BACLOFEN	10MG	TABLET / ORAL	2007-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077971-002	BACLOFEN	20MG	TABLET / ORAL	2007-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077971-003	BACLOFEN	5MG	TABLET / ORAL	2021-07-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077971-001	BACLOFEN	10MG	TABLET / ORAL	2007-10-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077971-002	BACLOFEN	20MG	TABLET / ORAL	2007-10-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077971-003	BACLOFEN	5MG	TABLET / ORAL	2021-07-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077971-001	BACLOFEN	10MG	TABLET / ORAL	2007-10-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077971-002	BACLOFEN	20MG	TABLET / ORAL	2007-10-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077971-003	BACLOFEN	5MG	TABLET / ORAL	2021-07-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077971-001	BACLOFEN	10MG	TABLET / ORAL	2007-10-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077971-002	BACLOFEN	20MG	TABLET / ORAL	2007-10-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077971-003	BACLOFEN	5MG	TABLET / ORAL	2021-07-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077971-001	BACLOFEN	10MG	TABLET / ORAL	2007-10-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077971-002	BACLOFEN	20MG	TABLET / ORAL	2007-10-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077971-003	BACLOFEN	5MG	TABLET / ORAL	2021-07-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077971-001	BACLOFEN	10MG	TABLET / ORAL	2007-10-26	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 70 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077971-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077971-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077971-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077971-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077971-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077971-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077971-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077971-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077971-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077971-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077971-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077971-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077971-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077971-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077971-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077971-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077971-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077971-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077971-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077971-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077971-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077971-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077971-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077971-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077971-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077971-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077971-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077971-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077971-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077971-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077971-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077971-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077971-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077971-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077971-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A077971-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A077971-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077971-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A077971-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A077971-003	AB	1	`ea1830bbd6c7…`

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 4 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	8a39dbc7-99d7-49e4-b5a1-cf70e7d753b2	2025-11-12	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Northstar RxLLC	0aac77fa-30c2-46c8-a04d-e6b8333ddd81	2025-11-05	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
BACLOFEN	BACLOFEN	Major Pharmaceuticals	f328296e-0713-4acb-bcb5-c10d7838d380	2025-10-29	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
Baclofen	BACLOFEN	PD-Rx Pharmaceuticals, Inc.	95755a7b-4a9f-45ea-a381-d3f661150efe	2025-10-20	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	PD-Rx Pharmaceuticals, Inc.	cfcf519f-5d15-431d-89c8-961a0c38ba60	2025-10-17	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
BACLOFEN	BACLOFEN	PD-Rx Pharmaceuticals, Inc.	5cba5255-e5ad-48fd-8385-60e9ea6b6407	2025-10-09	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
Baclofen	BACLOFEN	Bryant Ranch Prepack	0a5940cd-63eb-4d1b-8e92-44df264bc05a	2025-10-03	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Bryant Ranch Prepack	ab5fd609-3081-4400-90cd-c83b6834d381	2025-10-03	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Marlex Pharmaceuticals Inc	1b0f50c8-62e3-414d-96d3-5fd16e8043ab	2025-09-22	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
BACLOFEN	BACLOFEN	Bryant Ranch Prepack	844a09ab-6c11-44fa-a09b-09e2b7a3759e	2025-08-25	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
BACLOFEN	BACLOFEN	Asclemed USA, Inc.	35bccefe-8d2e-85b5-e063-6394a90a58ca	2025-08-13	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
Baclofen	BACLOFEN	American Health Packaging	8b046ee6-28fc-4ab1-b543-414ad0103e5c	2025-08-04	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Method Pharmaceuticals LLC	1a9db542-d2b0-141a-e063-6394a90acc11	2025-07-23	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
BACLOFEN	BACLOFEN	Trifluent Pharma, LLC	890df151-f4eb-4244-97c4-f1f10912e753	2025-07-21	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
Baclofen	BACLOFEN	Bryant Ranch Prepack	a748da19-d3eb-499e-986c-2043a1356f2b	2025-07-15	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
BACLOFEN	BACLOFEN	A-S Medication Solutions	eb690a49-b87b-433f-9afe-2966406fe00e	2025-07-15	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
BACLOFEN	BACLOFEN	A-S Medication Solutions	af0ade6c-9dd4-42d3-879e-4201fbe585ee	2025-07-15	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
Baclofen	BACLOFEN	Aphena Pharma Solutions - Tennessee, LLC	39ad22ca-f034-f605-e063-6294a90a08e4	2025-07-11	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Aphena Pharma Solutions - Tennessee, LLC	3981db3e-672c-1634-e063-6294a90a4cd1	2025-07-09	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Bryant Ranch Prepack	3ac0f0d2-86d8-46d0-88e5-c243734b0814	2025-06-26	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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0115-1010	Baclofen	Baclofen	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1010	Baclofen	Baclofen	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1010	Baclofen	Baclofen	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1010	Baclofen	Baclofen	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1010	Baclofen	Baclofen	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1011	Baclofen	Baclofen	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1011	Baclofen	Baclofen	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1011	Baclofen	Baclofen	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1012	Baclofen	Baclofen	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1012	Baclofen	Baclofen	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1012	Baclofen	Baclofen	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1012	Baclofen	Baclofen	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0115-1012	Baclofen	Baclofen	Amneal Pharmaceuticals of New York LLC	ANDA	Current
0615-8411	Baclofen	Baclofen	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8412	Baclofen	Baclofen	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current