Application 211659

Type: ANDA
Sponsor: ZYDUS

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
004	BACLOFEN	BACLOFEN	TABLET;ORAL	15MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A211659-001	BACLOFEN	BACLOFEN	10MG	TABLET / ORAL	AB	2018-11-23
A211659-002	BACLOFEN	BACLOFEN	20MG	TABLET / ORAL	AB	2018-11-23
A211659-003	BACLOFEN	BACLOFEN	5MG	TABLET / ORAL	AB	2020-04-17
A211659-004	BACLOFEN	BACLOFEN	15MG	TABLET / ORAL	AB	2024-02-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A211659-001	AB
A211659-002	AB
A211659-003	AB
A211659-004	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 · 135 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	A211659-001	BACLOFEN	10MG	TABLET / ORAL	AB	2018-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211659-002	BACLOFEN	20MG	TABLET / ORAL	AB	2018-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211659-003	BACLOFEN	5MG	TABLET / ORAL	AB	2020-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211659-004	BACLOFEN	15MG	TABLET / ORAL	AB	2024-02-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211659-001	BACLOFEN	10MG	TABLET / ORAL	AB	2018-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211659-002	BACLOFEN	20MG	TABLET / ORAL	AB	2018-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211659-003	BACLOFEN	5MG	TABLET / ORAL	AB	2020-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211659-004	BACLOFEN	15MG	TABLET / ORAL	AB	2024-02-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211659-001	BACLOFEN	10MG	TABLET / ORAL	AB	2018-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211659-002	BACLOFEN	20MG	TABLET / ORAL	AB	2018-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211659-003	BACLOFEN	5MG	TABLET / ORAL	AB	2020-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211659-004	BACLOFEN	15MG	TABLET / ORAL	AB	2024-02-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211659-001	BACLOFEN	10MG	TABLET / ORAL	AB	2018-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211659-002	BACLOFEN	20MG	TABLET / ORAL	AB	2018-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211659-003	BACLOFEN	5MG	TABLET / ORAL	AB	2020-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211659-004	BACLOFEN	15MG	TABLET / ORAL	AB	2024-02-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211659-001	BACLOFEN	10MG	TABLET / ORAL	AB	2018-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211659-002	BACLOFEN	20MG	TABLET / ORAL	AB	2018-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211659-003	BACLOFEN	5MG	TABLET / ORAL	AB	2020-04-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211659-004	BACLOFEN	15MG	TABLET / ORAL	AB	2024-02-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211659-001	BACLOFEN	10MG	TABLET / ORAL	AB	2018-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211659-002	BACLOFEN	20MG	TABLET / ORAL	AB	2018-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211659-003	BACLOFEN	5MG	TABLET / ORAL	AB	2020-04-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211659-004	BACLOFEN	15MG	TABLET / ORAL	AB	2024-02-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211659-001	BACLOFEN	10MG	TABLET / ORAL	AB	2018-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211659-002	BACLOFEN	20MG	TABLET / ORAL	AB	2018-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211659-003	BACLOFEN	5MG	TABLET / ORAL	AB	2020-04-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211659-004	BACLOFEN	15MG	TABLET / ORAL	AB	2024-02-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211659-001	BACLOFEN	10MG	TABLET / ORAL	AB	2018-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211659-002	BACLOFEN	20MG	TABLET / ORAL	AB	2018-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211659-003	BACLOFEN	5MG	TABLET / ORAL	AB	2020-04-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211659-004	BACLOFEN	15MG	TABLET / ORAL	AB	2024-02-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211659-001	BACLOFEN	10MG	TABLET / ORAL	AB	2018-11-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211659-002	BACLOFEN	20MG	TABLET / ORAL	AB	2018-11-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211659-003	BACLOFEN	5MG	TABLET / ORAL	AB	2020-04-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211659-004	BACLOFEN	15MG	TABLET / ORAL	AB	2024-02-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211659-001	BACLOFEN	10MG	TABLET / ORAL	AB	2018-11-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211659-002	BACLOFEN	20MG	TABLET / ORAL	AB	2018-11-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211659-003	BACLOFEN	5MG	TABLET / ORAL	AB	2020-04-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211659-004	BACLOFEN	15MG	TABLET / ORAL	AB	2024-02-13	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 135 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	A211659-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211659-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211659-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211659-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211659-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211659-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211659-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211659-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211659-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211659-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211659-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211659-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211659-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211659-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211659-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211659-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211659-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211659-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211659-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211659-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211659-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211659-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211659-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211659-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211659-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211659-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211659-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211659-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211659-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211659-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211659-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211659-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211659-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211659-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211659-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211659-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211659-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211659-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211659-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211659-004	AB	1	`d06236e962d9…`

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Baclofen	BACLOFEN	Cardinal Health 107, LLC	3c87e116-871d-46b8-897b-fc27a17b988d	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211659 application number: ANDA211659
Baclofen	BACLOFEN	AvPAK	c21095a9-17b1-555a-e053-2a95a90a51fd	2026-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211659 application number: ANDA211659 ndc (product): 50268-105
Baclofen	BACLOFEN	AvPAK	bc9040d9-1c54-9d62-e053-2a95a90a6ae3	2026-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211659 application number: ANDA211659 ndc (product): 50268-106 ndc (product): 50268-107
Baclofen	BACLOFEN	Coupler LLC	5023c690-fd86-bb7d-e063-6394a90af6cd	2026-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211659 application number: ANDA211659
Baclofen	BACLOFEN	A-S Medication Solutions	4f84b27a-725a-48e6-a58a-85bbb395f4ae	2026-03-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211659 application number: ANDA211659
Baclofen	BACLOFEN	A-S Medication Solutions	5f6a86f9-9658-4210-a47c-62907edfd416	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211659 application number: ANDA211659 ndc (product): 50090-6149
Baclofen	BACLOFEN	A-S Medication Solutions	975fda6d-d929-482b-8be7-60849026dbdd	2026-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211659 application number: ANDA211659 ndc (product): 50090-4682
Baclofen	BACLOFEN	American Health Packaging	8b046ee6-28fc-4ab1-b543-414ad0103e5c	2025-08-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211659 application number: ANDA211659
Baclofen	BACLOFEN	Bryant Ranch Prepack	5b92b0a6-ebba-4815-8b94-f2014674399b	2024-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211659 application number: ANDA211659 ndc (product): 71335-1356
Baclofen	BACLOFEN	Zydus Lifesciences Limited	bb5c6faa-2933-44d1-8706-8302150be734	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211659 application number: ANDA211659 ndc (product): 70771-1448 ndc (product): 70771-1449 ndc (product): 70771-1586
Baclofen	BACLOFEN	Zydus Pharmaceuticals (USA) Inc.	cfc49176-8d01-4c39-9319-604dd087065c	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211659 application number: ANDA211659 ndc (product): 70710-1609 ndc (product): 70710-1285 ndc (product): 70710-1286

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 38 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-4682	Baclofen	Baclofen	A-S Medication Solutions	ANDA	Current
50090-4682	Baclofen	Baclofen	A-S Medication Solutions	ANDA	Current
50090-6149	Baclofen	Baclofen	A-S Medication Solutions	ANDA	Current
50268-105	Baclofen	Baclofen	AvPAK	ANDA	Current
50268-105	Baclofen	Baclofen	AvPAK	ANDA	Current
50268-106	Baclofen	Baclofen	AvPAK	ANDA	Current
50268-106	Baclofen	Baclofen	AvPAK	ANDA	Current
50268-107	Baclofen	Baclofen	AvPAK	ANDA	Current
50268-107	Baclofen	Baclofen	AvPAK	ANDA	Current
68788-7551	Baclofen	Baclofen	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7551	Baclofen	Baclofen	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7562	Baclofen	Baclofen	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7562	Baclofen	Baclofen	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-2470	Baclofen	Baclofen	REMEDYREPACK INC.	ANDA	Current
70710-1285	Baclofen	Baclofen	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1285	Baclofen	Baclofen	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1285	Baclofen	Baclofen	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1285	Baclofen	Baclofen	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1285	Baclofen	Baclofen	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1286	Baclofen	Baclofen	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1286	Baclofen	Baclofen	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1286	Baclofen	Baclofen	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1286	Baclofen	Baclofen	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1286	Baclofen	Baclofen	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1609	Baclofen	Baclofen	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1609	Baclofen	Baclofen	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1448	Baclofen	Baclofen	Cadila Healthcare Limited	ANDA	Current
70771-1448	Baclofen	Baclofen	Cadila Healthcare Limited	ANDA	Current
70771-1448	Baclofen	Baclofen	Cadila Healthcare Limited	ANDA	Current
70771-1448	Baclofen	Baclofen	Cadila Healthcare Limited	ANDA	Current
70771-1449	Baclofen	Baclofen	Cadila Healthcare Limited	ANDA	Current
70771-1449	Baclofen	Baclofen	Cadila Healthcare Limited	ANDA	Current
70771-1449	Baclofen	Baclofen	Cadila Healthcare Limited	ANDA	Current
70771-1449	Baclofen	Baclofen	Cadila Healthcare Limited	ANDA	Current
70771-1586	Baclofen	Baclofen	Cadila Healthcare Limited	ANDA	Current
70771-1586	Baclofen	Baclofen	Cadila Healthcare Limited	ANDA	Current
71335-1356	Baclofen	Baclofen	Bryant Ranch Prepack	ANDA	Current
71335-1356	Baclofen	Baclofen	Bryant Ranch Prepack	ANDA	Current