Application 072234

Type: ANDA
Sponsor: IVAX SUB TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A072234-001	BACLOFEN	BACLOFEN	10MG	TABLET / ORAL	AB		1988-07-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A072234-001	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 2 · 41 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	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A072234-001	BACLOFEN	10MG	TABLET / ORAL	AB	1988-07-21	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A072234-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072234-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072234-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072234-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072234-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072234-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072234-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072234-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072234-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072234-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072234-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072234-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072234-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072234-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072234-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072234-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072234-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072234-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072234-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072234-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072234-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072234-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072234-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072234-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072234-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072234-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072234-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072234-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072234-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072234-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072234-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072234-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072234-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072234-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072234-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072234-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072234-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072234-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072234-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A072234-001	AB	1	`cb3db0bc1861…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Baclofen	BACLOFEN	Northwind Health Company, LLC	06bcfb08-2ada-f803-e063-6394a90a826b	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072234 application number: ANDA072234
Baclofen	BACLOFEN	PD-Rx Pharmaceuticals, Inc.	95755a7b-4a9f-45ea-a381-d3f661150efe	2025-10-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072234 application number: ANDA072234 ndc (product): 55289-757
Baclofen	BACLOFEN	Advanced Rx of Tennessee, LLC	b33c4164-e607-2e27-e053-2a95a90ad7db	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072234 application number: ANDA072234 ndc (product): 80425-0080
Baclofen	BACLOFEN	Proficient Rx LP	b981eb16-a195-41da-a186-3e91b63b2def	2024-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072234 application number: ANDA072234 ndc (product): 63187-147
Baclofen	BACLOFEN	Teva Pharmaceuticals USA, Inc.	5648c772-50cb-4961-996e-e68a8eb699ea	2019-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072234 application number: ANDA072234 ndc (product): 0172-4096

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 39 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0172-4096	Baclofen	Baclofen	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0172-4096	Baclofen	Baclofen	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0172-4096	Baclofen	Baclofen	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0172-4096	Baclofen	Baclofen	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0615-3541	Baclofen	Baclofen	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-3541	Baclofen	Baclofen	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-3541	Baclofen	Baclofen	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0904-3365	Baclofen	Baclofen	Major Pharmaceuticals	ANDA	Current
42254-061	Baclofen	Baclofen	Rebel Distributors Corp	ANDA	Current
50090-0564	Baclofen	Baclofen	A-S Medication Solutions	ANDA	Current
50090-0564	Baclofen	Baclofen	A-S Medication Solutions	ANDA	Current
50436-9022	Baclofen	Baclofen	Unit Dose Services	ANDA	Current
50436-9022	Baclofen	Baclofen	Unit Dose Services	ANDA	Current
52959-733	Baclofen	Baclofen	H.J. Harkins Company, Inc.	ANDA	Current
55289-757	Baclofen	Baclofen	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-757	Baclofen	Baclofen	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-757	Baclofen	Baclofen	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-757	Baclofen	Baclofen	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-757	Baclofen	Baclofen	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-757	Baclofen	Baclofen	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
61919-026	BACLOFEN	BACLOFEN	Direct Rx	ANDA	Current
61919-026	BACLOFEN	BACLOFEN	Direct Rx	ANDA	Current
63187-147	Baclofen	Baclofen	Proficient Rx LP	ANDA	Current
63187-147	Baclofen	Baclofen	Proficient Rx LP	ANDA	Current
63187-147	Baclofen	Baclofen	Proficient Rx LP	ANDA	Current
63629-6883	Baclofen	Baclofen	Bryant Ranch Prepack	ANDA	Current
63629-6883	Baclofen	Baclofen	Bryant Ranch Prepack	ANDA	Current
68788-9846	Baclofen	Baclofen	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9846	Baclofen	Baclofen	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-0547	Baclofen	Baclofen	REMEDYREPACK INC.	ANDA	Current
70518-0547	Baclofen	Baclofen	REMEDYREPACK INC.	ANDA	Current
70518-1515	Baclofen	Baclofen	REMEDYREPACK INC.	ANDA	Current
70518-1515	Baclofen	Baclofen	REMEDYREPACK INC.	ANDA	Current
70518-1515	Baclofen	Baclofen	REMEDYREPACK INC.	ANDA	Current
80425-0080	Baclofen	Baclofen 10mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0080	Baclofen	Baclofen 10mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0080	Baclofen	Baclofen	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0080	Baclofen	Baclofen	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0080	Baclofen	Baclofen	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current