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 1.

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 3 · 115 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077971-002	BACLOFEN	20MG	TABLET / ORAL	2007-10-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077971-003	BACLOFEN	5MG	TABLET / ORAL	2021-07-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077971-001	BACLOFEN	10MG	TABLET / ORAL	2007-10-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077971-002	BACLOFEN	20MG	TABLET / ORAL	2007-10-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077971-003	BACLOFEN	5MG	TABLET / ORAL	2021-07-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077971-001	BACLOFEN	10MG	TABLET / ORAL	2007-10-26	`8072bd15b7f6…`

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 1 of 9 · 169 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Baclofen	BACLOFEN	Atlantic Biologicals Corp.	50b3e7be-832b-313d-e063-6394a90a5ab4	2026-08-05	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	REMEDYREPACK INC.	76896b07-2835-4467-b386-87ec66ddd88e	2026-08-04	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Rosemont Pharmaceuticals LLC	81a539b3-e547-4a62-ad1b-2eedb30be927	2026-08-04	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Cardinal Health 107, LLC	3c87e116-871d-46b8-897b-fc27a17b988d	2026-07-24	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Preferred Pharmaceuticals Inc.	3047613d-006b-4011-b5fe-098588f474aa	2026-07-22	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	REMEDYREPACK INC.	6274e70a-fb57-461b-b1bc-39d4ff916b2a	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	REMEDYREPACK INC.	ebbfec9e-621c-4d04-8a1c-81d2eb9e9c74	2026-06-30	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	AvPAK	c21095a9-17b1-555a-e053-2a95a90a51fd	2026-06-29	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
BACLOFEN	BACLOFEN	NuCare Pharmaceuticals, Inc.	2517f71f-f452-1f56-e063-6394a90a6ef1	2026-06-25	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
BACLOFEN	BACLOFEN	Redpharm Drug	53df4b4b-842e-9e3a-e063-6394a90a8a3d	2026-06-10	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
Baclofen	BACLOFEN	REMEDYREPACK INC.	d689d32c-12a7-4ae4-afc3-8a353be67148	2026-06-01	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Eywa Pharma Inc	7ec59f6b-7c4f-432d-ba27-442861806b6c	2026-05-16	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
BACLOFEN	BACLOFEN	REMEDYREPACK INC.	e017a001-8cb1-4dd8-960e-c6d74005f57f	2026-05-12	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
Baclofen	BACLOFEN	AvPAK	bc9040d9-1c54-9d62-e053-2a95a90a6ae3	2026-05-06	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Coupler LLC	5023c690-fd86-bb7d-e063-6394a90af6cd	2026-04-23	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Cardinal Health 107, LLC	2278954a-7605-426a-ae85-1bf0a3117420	2026-04-22	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Golden State Medical Supply, Inc.	32336e92-89a4-7d7f-e063-6394a90ae924	2026-04-21	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
BACLOFEN	BACLOFEN	REMEDYREPACK INC.	ac9b720f-b755-49f1-9850-efb26feadaeb	2026-04-14	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
BACLOFEN	BACLOFEN	Cardinal Health 107, LLC	a0cdf5e0-45cb-41e0-a6f1-6e3aaf02b67c	2026-04-13	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
BACLOFEN	BACLOFEN	REMEDYREPACK INC.	355266e4-68f7-47d7-9f4e-1a0fc912786d	2026-04-10	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN

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