Application 072235

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	20MG	No	Yes

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
A072235-001	BACLOFEN	BACLOFEN	20MG	TABLET / ORAL	AB	RS	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
A072235-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	1988-07-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A072235-001	BACLOFEN	20MG	TABLET / ORAL	AB	RS	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	A072235-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072235-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072235-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072235-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072235-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072235-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072235-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072235-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072235-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072235-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072235-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072235-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072235-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072235-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072235-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072235-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072235-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072235-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072235-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072235-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072235-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072235-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072235-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072235-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072235-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072235-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072235-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072235-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072235-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072235-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072235-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072235-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072235-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072235-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072235-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072235-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072235-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072235-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072235-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A072235-001	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Baclofen	BACLOFEN	Proficient Rx LP	9d5a10cf-9a99-41eb-b4b8-9cf4cfaff6fc	2024-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072235 application number: ANDA072235 ndc (product): 63187-274
Baclofen	BACLOFEN	Teva Pharmaceuticals USA, Inc.	5648c772-50cb-4961-996e-e68a8eb699ea	2019-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 072235 application number: ANDA072235 ndc (product): 0172-4097

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 24 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0172-4097	Baclofen	Baclofen	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0172-4097	Baclofen	Baclofen	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0172-4097	Baclofen	Baclofen	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0172-4097	Baclofen	Baclofen	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0615-3542	Baclofen	Baclofen	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-3542	Baclofen	Baclofen	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-3542	Baclofen	Baclofen	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0904-5222	Baclofen	Baclofen	Major Pharmaceuticals	ANDA	Current
42254-029	Baclofen	Baclofen	Rebel Distributors Corp	ANDA	Current
50090-2109	Baclofen	Baclofen	A-S Medication Solutions	ANDA	Current
50436-9023	Baclofen	Baclofen	Unit Dose Services	ANDA	Current
52959-677	Baclofen	Baclofen	H.J. Harkins Company, Inc.	ANDA	Current
55700-236	Baclofen	Baclofen	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
61919-027	BACLOFEN	BACLOFEN	Direct Rx	ANDA	Current
61919-027	BACLOFEN	BACLOFEN	Direct Rx	ANDA	Current
63187-274	Baclofen	Baclofen	Proficient Rx LP	ANDA	Current
63187-274	Baclofen	Baclofen	Proficient Rx LP	ANDA	Current
63187-274	Baclofen	Baclofen	Proficient Rx LP	ANDA	Current
68071-4905	Baclofen	Baclofen	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4905	Baclofen	Baclofen	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-6903	Baclofen	Baclofen	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6903	Baclofen	Baclofen	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-0411	Baclofen	Baclofen	REMEDYREPACK INC.	ANDA	Current
70518-0411	Baclofen	Baclofen	REMEDYREPACK INC.	ANDA	Current