Application 212378

Type: ANDA
Sponsor: INNOGENIX

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	TE codes	Approval date
A212378-001	BACLOFEN	BACLOFEN	10MG	TABLET / ORAL	AB	2020-10-09
A212378-002	BACLOFEN	BACLOFEN	20MG	TABLET / ORAL	AB	2020-10-09
A212378-003	BACLOFEN	BACLOFEN	5MG	TABLET / ORAL	AB	2021-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212378-001	AB
A212378-002	AB
A212378-003	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 3 · 105 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
2026-02-19 14:30 UTC	2026-02	A212378-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-10-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212378-002	BACLOFEN	20MG	TABLET / ORAL	AB	2020-10-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212378-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212378-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-10-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212378-002	BACLOFEN	20MG	TABLET / ORAL	AB	2020-10-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212378-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212378-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-10-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212378-002	BACLOFEN	20MG	TABLET / ORAL	AB	2020-10-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212378-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212378-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-10-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212378-002	BACLOFEN	20MG	TABLET / ORAL	AB	2020-10-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212378-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212378-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-10-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212378-002	BACLOFEN	20MG	TABLET / ORAL	AB	2020-10-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212378-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212378-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-10-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212378-002	BACLOFEN	20MG	TABLET / ORAL	AB	2020-10-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212378-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212378-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-10-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212378-002	BACLOFEN	20MG	TABLET / ORAL	AB	2020-10-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212378-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-04-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212378-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-10-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212378-002	BACLOFEN	20MG	TABLET / ORAL	AB	2020-10-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212378-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-04-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212378-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-10-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212378-002	BACLOFEN	20MG	TABLET / ORAL	AB	2020-10-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212378-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-04-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212378-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-10-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212378-002	BACLOFEN	20MG	TABLET / ORAL	AB	2020-10-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212378-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-04-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212378-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-10-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212378-002	BACLOFEN	20MG	TABLET / ORAL	AB	2020-10-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212378-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-04-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212378-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-10-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212378-002	BACLOFEN	20MG	TABLET / ORAL	AB	2020-10-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212378-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-04-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212378-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-10-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212378-002	BACLOFEN	20MG	TABLET / ORAL	AB	2020-10-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212378-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-04-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212378-001	BACLOFEN	10MG	TABLET / ORAL	AB	2020-10-09	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 105 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212378-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212378-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212378-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212378-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212378-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212378-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212378-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212378-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212378-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212378-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212378-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212378-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212378-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212378-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212378-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212378-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212378-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212378-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212378-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212378-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212378-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212378-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212378-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212378-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212378-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212378-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212378-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212378-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212378-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212378-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212378-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212378-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212378-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212378-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212378-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212378-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212378-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212378-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212378-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212378-001	AB	1	`8072bd15b7f6…`

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 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Baclofen	BACLOFEN	REMEDYREPACK INC.	6274e70a-fb57-461b-b1bc-39d4ff916b2a	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212378 application number: ANDA212378 ndc (product): 70518-3115
Baclofen	BACLOFEN	REMEDYREPACK INC.	d689d32c-12a7-4ae4-afc3-8a353be67148	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212378 application number: ANDA212378 ndc (product): 70518-3089
Baclofen	BACLOFEN	Bryant Ranch Prepack	80b0a41e-2cad-4e14-9605-0cd35f9991e9	2026-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212378 application number: ANDA212378
Baclofen	BACLOFEN	Bryant Ranch Prepack	808113db-c5c2-404c-ab5f-62b991641cfe	2026-01-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212378 application number: ANDA212378 ndc (product): 71335-1796
Baclofen	BACLOFEN	Bryant Ranch Prepack	8a39dbc7-99d7-49e4-b5a1-cf70e7d753b2	2025-11-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212378 application number: ANDA212378
Baclofen	BACLOFEN	Bryant Ranch Prepack	0a5940cd-63eb-4d1b-8e92-44df264bc05a	2025-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212378 application number: ANDA212378
Baclofen	BACLOFEN	Method Pharmaceuticals LLC	1a9db542-d2b0-141a-e063-6394a90acc11	2025-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212378 application number: ANDA212378
Baclofen	BACLOFEN	Bryant Ranch Prepack	a748da19-d3eb-499e-986c-2043a1356f2b	2025-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212378 application number: ANDA212378
Baclofen	BACLOFEN	Bryant Ranch Prepack	3ac0f0d2-86d8-46d0-88e5-c243734b0814	2025-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212378 application number: ANDA212378
BACLOFEN	BACLOFEN	XLCare Pharmaceuticals Inc.	2b4908fb-47b5-4675-be9e-ca1ad48a7252	2025-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212378 application number: ANDA212378
Baclofen	BACLOFEN	Advanced Rx Pharmacy of Tennessee, LLC	c85a1884-f46f-5cd4-e053-2a95a90a3e27	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212378 application number: ANDA212378 ndc (product): 80425-0156
Baclofen	BACLOFEN	Advanced Rx Pharmacy of Tennessee, LLC	ec09736a-dd2b-0a3b-e053-2995a90a9542	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212378 application number: ANDA212378 ndc (product): 80425-0205
Baclofen	BACLOFEN	Bryant Ranch Prepack	43cafbdb-6927-45f6-9b16-3b125cc2a29d	2024-11-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212378 application number: ANDA212378
Baclofen	BACLOFEN	Advanced Rx Pharmacy of Tennessee, LLC	f5edb656-4f7e-2386-e053-2995a90a70de	2024-11-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212378 application number: ANDA212378
Baclofen	BACLOFEN	Bryant Ranch Prepack	08a6866f-b127-482f-9f22-113175487bdd	2024-09-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212378 application number: ANDA212378
Baclofen	BACLOFEN	Bryant Ranch Prepack	4634093b-6def-41d6-a7f3-23040125c4f4	2024-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212378 application number: ANDA212378
Baclofen	BACLOFEN	Bryant Ranch Prepack	655db2a3-daf7-4f4b-8f64-4a6d81fdc165	2024-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212378 application number: ANDA212378
Baclofen	BACLOFEN	Bryant Ranch Prepack	d24135b3-e247-412f-a10b-ceecbdee3aef	2024-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212378 application number: ANDA212378 ndc (product): 63629-1228
Baclofen	BACLOFEN	Bryant Ranch Prepack	80a4c6f7-4f02-493c-9263-62e1c90404ba	2024-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212378 application number: ANDA212378 ndc (product): 63629-1224
Baclofen	BACLOFEN	Bryant Ranch Prepack	ff8e9fa8-5f06-4902-b1ac-a7fc09ccddbb	2024-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212378 application number: ANDA212378 ndc (product): 63629-1227

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 40 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
31722-138	Baclofen	Baclofen	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-998	Baclofen	Baclofen	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-998	Baclofen	Baclofen	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-999	Baclofen	Baclofen	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-999	Baclofen	Baclofen	Camber Pharmaceuticals, Inc.	ANDA	Current
50090-5838	Baclofen	Baclofen	A-S Medication Solutions	ANDA	Current
50090-5855	Baclofen	Baclofen	A-S Medication Solutions	ANDA	Current
63629-1224	Baclofen	Baclofen	Bryant Ranch Prepack	ANDA	Current
63629-1224	Baclofen	Baclofen	Bryant Ranch Prepack	ANDA	Current
63629-1224	Baclofen	Baclofen	Bryant Ranch Prepack	ANDA	Current
63629-1225	Baclofen	Baclofen	Bryant Ranch Prepack	ANDA	Current
63629-1225	Baclofen	Baclofen	Bryant Ranch Prepack	ANDA	Current
63629-1225	Baclofen	Baclofen	Bryant Ranch Prepack	ANDA	Current
63629-1226	Baclofen	Baclofen	Bryant Ranch Prepack	ANDA	Current
63629-1226	Baclofen	Baclofen	Bryant Ranch Prepack	ANDA	Current
63629-1226	Baclofen	Baclofen	Bryant Ranch Prepack	ANDA	Current
63629-1227	Baclofen	Baclofen	Bryant Ranch Prepack	ANDA	Current
63629-1227	Baclofen	Baclofen	Bryant Ranch Prepack	ANDA	Current
63629-1227	Baclofen	Baclofen	Bryant Ranch Prepack	ANDA	Current
63629-1228	Baclofen	Baclofen	Bryant Ranch Prepack	ANDA	Current
63629-1228	Baclofen	Baclofen	Bryant Ranch Prepack	ANDA	Current
63629-1228	Baclofen	Baclofen	Bryant Ranch Prepack	ANDA	Current
68071-2414	Baclofen	Baclofen	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2414	Baclofen	Baclofen	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2420	Baclofen	Baclofen	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7915	Baclofen	Baclofen	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7915	Baclofen	Baclofen	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-8181	Baclofen	Baclofen	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-3089	Baclofen	Baclofen	REMEDYREPACK INC.	ANDA	Current
70518-3089	Baclofen	Baclofen	REMEDYREPACK INC.	ANDA	Current
70518-3115	Baclofen	Baclofen	REMEDYREPACK INC.	ANDA	Current
70518-3115	Baclofen	Baclofen	REMEDYREPACK INC.	ANDA	Current
71335-1796	Baclofen	Baclofen	Bryant Ranch Prepack	ANDA	Current
71335-1797	Baclofen	Baclofen	Bryant Ranch Prepack	ANDA	Current
71610-660	Baclofen	Baclofen	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
80425-0156	Baclofen	Baclofen 10mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0156	Baclofen	Baclofen	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0156	Baclofen	Baclofen	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0156	Baclofen	Baclofen	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0205	Baclofen	Baclofen	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current