Application 077241

Type: ANDA
Sponsor: LANNETT CO INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BACLOFEN	BACLOFEN	TABLET;ORAL	20MG	No	No
002	BACLOFEN	BACLOFEN	TABLET;ORAL	10MG	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
A077241-001	BACLOFEN	BACLOFEN	20MG	TABLET / ORAL	AB	2005-12-20
A077241-002	BACLOFEN	BACLOFEN	10MG	TABLET / ORAL	AB	2007-07-06
A077241-003	BACLOFEN	BACLOFEN	5MG	TABLET / ORAL	AB	2021-09-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077241-001	AB
A077241-002	AB
A077241-003	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 4 · 121 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	A077241-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077241-002	BACLOFEN	10MG	TABLET / ORAL	AB	2007-07-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077241-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-09-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077241-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077241-002	BACLOFEN	10MG	TABLET / ORAL	AB	2007-07-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077241-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-09-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077241-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077241-002	BACLOFEN	10MG	TABLET / ORAL	AB	2007-07-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077241-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-09-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077241-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077241-002	BACLOFEN	10MG	TABLET / ORAL	AB	2007-07-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077241-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-09-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077241-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077241-002	BACLOFEN	10MG	TABLET / ORAL	AB	2007-07-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077241-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-09-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077241-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077241-002	BACLOFEN	10MG	TABLET / ORAL	AB	2007-07-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077241-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-09-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077241-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077241-002	BACLOFEN	10MG	TABLET / ORAL	AB	2007-07-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077241-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-09-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077241-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077241-002	BACLOFEN	10MG	TABLET / ORAL	AB	2007-07-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077241-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-09-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077241-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077241-002	BACLOFEN	10MG	TABLET / ORAL	AB	2007-07-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077241-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-09-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077241-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-12-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077241-002	BACLOFEN	10MG	TABLET / ORAL	AB	2007-07-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077241-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-09-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077241-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-12-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077241-002	BACLOFEN	10MG	TABLET / ORAL	AB	2007-07-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077241-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-09-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077241-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-12-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077241-002	BACLOFEN	10MG	TABLET / ORAL	AB	2007-07-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077241-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-09-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077241-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-12-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077241-002	BACLOFEN	10MG	TABLET / ORAL	AB	2007-07-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077241-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-09-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077241-001	BACLOFEN	20MG	TABLET / ORAL	AB	2005-12-20	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 121 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	A077241-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077241-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077241-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077241-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077241-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077241-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077241-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077241-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077241-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077241-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077241-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077241-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077241-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077241-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077241-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077241-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077241-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077241-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077241-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077241-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077241-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077241-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077241-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077241-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077241-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077241-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077241-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077241-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077241-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077241-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077241-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077241-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077241-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077241-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077241-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077241-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077241-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077241-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077241-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077241-001	AB	1	`301d65b070ca…`

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 1 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Baclofen	BACLOFEN	Cardinal Health 107, LLC	2278954a-7605-426a-ae85-1bf0a3117420	2026-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077241 application number: ANDA077241
Baclofen	BACLOFEN	Major Pharmaceuticals	ae732bdc-5178-4565-8219-d1787a5211a6	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077241 application number: ANDA077241
Baclofen	BACLOFEN	PD-Rx Pharmaceuticals, Inc.	cfcf519f-5d15-431d-89c8-961a0c38ba60	2025-10-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077241 application number: ANDA077241
Baclofen	BACLOFEN	Marlex Pharmaceuticals Inc	1b0f50c8-62e3-414d-96d3-5fd16e8043ab	2025-09-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077241 application number: ANDA077241
Baclofen	BACLOFEN	Advanced Rx Pharmacy of Tennessee, LLC	b4f2f888-979a-6f54-e053-2a95a90a95a3	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077241 application number: ANDA077241 ndc (product): 80425-0112
Baclofen	BACLOFEN	Chartwell RX, LLC	2a75db96-590a-43cf-aefb-3bbcb287dbf0	2024-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077241 application number: ANDA077241
Baclofen	BACLOFEN	Bryant Ranch Prepack	7f27f935-b1fa-4494-9014-7f62c59bb8e3	2024-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077241 application number: ANDA077241
Baclofen	BACLOFEN	Bryant Ranch Prepack	b4506087-be24-4e76-9fb8-b07805137072	2024-01-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077241 application number: ANDA077241
Baclofen	BACLOFEN	Aphena Pharma Solutions - Tennessee, LLC	c582972d-22ef-4326-b37f-adf2ca0b1875	2023-12-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077241 application number: ANDA077241 ndc (product): 71610-444
Baclofen	BACLOFEN	Bryant Ranch Prepack	58816b46-28a5-48e2-b89d-98df65939386	2023-10-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077241 application number: ANDA077241 ndc (product): 71335-0103
Baclofen	BACLOFEN	Bryant Ranch Prepack	9110b1cb-8604-4824-9337-84b08d41dd3c	2023-10-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077241 application number: ANDA077241
Baclofen	BACLOFEN	Lannett Company, Inc.	f84f3f4c-17e6-43f1-9600-63b0b175837b	2021-02-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077241 application number: ANDA077241
Baclofen	BACLOFEN	Proficient Rx LP	924a01fb-0ed0-4f73-9304-d6c5b9961d66	2020-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077241 application number: ANDA077241

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 2 of 2 · 91 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71335-0103	Baclofen	baclofen	Bryant Ranch Prepack	ANDA	Current
71610-444	Baclofen	baclofen	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-444	Baclofen	baclofen	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-444	Baclofen	baclofen	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-444	Baclofen	baclofen	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-614	Baclofen	baclofen	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
80425-0112	Baclofen	Baclofen 20mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0112	Baclofen	Baclofen 20mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0112	Baclofen	Baclofen	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0112	Baclofen	Baclofen	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0112	Baclofen	Baclofen	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current