Application 078401

Type: ANDA
Sponsor: NORTHSTAR HLTHCARE

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078401-001	BACLOFEN	BACLOFEN	20MG	TABLET / ORAL	AB		2009-09-18
A078401-002	BACLOFEN	BACLOFEN	10MG	TABLET / ORAL	AB		2009-09-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A078401-001	AB
A078401-002	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 · 82 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	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078401-001	BACLOFEN	20MG	TABLET / ORAL	AB	2009-09-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078401-002	BACLOFEN	10MG	TABLET / ORAL	AB	2009-09-18	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A078401-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078401-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078401-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078401-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078401-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078401-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078401-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078401-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078401-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078401-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078401-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078401-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078401-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078401-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078401-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078401-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078401-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078401-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078401-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078401-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078401-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078401-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078401-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078401-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078401-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078401-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078401-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078401-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078401-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078401-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078401-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078401-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078401-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078401-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078401-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078401-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078401-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078401-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078401-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078401-002	AB	1	`782e0a99824c…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Baclofen	BACLOFEN	A-S Medication Solutions	7ee42a29-21c2-47f8-a5b3-f3af115b665d	2026-02-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078401 application number: ANDA078401
Baclofen	BACLOFEN	Northstar RxLLC	0aac77fa-30c2-46c8-a04d-e6b8333ddd81	2025-11-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078401 application number: ANDA078401 ndc (product): 16714-072
Baclofen	BACLOFEN	Advanced Rx of Tennessee, LLC	b33c534d-4fa3-0a2f-e053-2995a90ab52f	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078401 application number: ANDA078401 ndc (product): 80425-0081
Baclofen	BACLOFEN	Aphena Pharma Solutions - Tennessee, LLC	9edc00c6-c281-4e81-b176-44b7536f71f2	2020-08-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078401 application number: ANDA078401 ndc (product): 71610-446

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-072	Baclofen	Baclofen	Northstar RxLLC	ANDA	Current
16714-072	Baclofen	Baclofen	Northstar RxLLC	ANDA	Current
16714-072	Baclofen	Baclofen	Northstar RxLLC	ANDA	Current
63739-480	Baclofen	Baclofen	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-480	Baclofen	Baclofen	Mckesson Corporation DBA SKY Packaginng	ANDA	Current
63739-480	Baclofen	Baclofen	McKesson Corporation	ANDA	Current
63739-480	Baclofen	Baclofen	Mckesson Corporation DBA SKY Packaginng	ANDA	Current
71610-446	Baclofen	Baclofen	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
71610-446	Baclofen	Baclofen	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
80425-0081	Baclofen	Baclofen 20mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0081	Baclofen	Baclofen	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0081	Baclofen	Baclofen	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0081	Baclofen	Baclofen	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current