Application 211555

Type: ANDA
Sponsor: EYWA PHARMA

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

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

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
A211555-001	BACLOFEN	BACLOFEN	10MG	TABLET / ORAL	AB	2019-02-01
A211555-002	BACLOFEN	BACLOFEN	20MG	TABLET / ORAL	AB	2019-02-01
A211555-003	BACLOFEN	BACLOFEN	5MG	TABLET / ORAL	AB	2021-11-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211555-001	AB
A211555-002	AB
A211555-003	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 3 · 114 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	A211555-001	BACLOFEN	10MG	TABLET / ORAL	BX	2019-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211555-002	BACLOFEN	20MG	TABLET / ORAL	BX	2019-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211555-003	BACLOFEN	5MG	TABLET / ORAL	BX	2021-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211555-001	BACLOFEN	10MG	TABLET / ORAL	BX	2019-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211555-002	BACLOFEN	20MG	TABLET / ORAL	BX	2019-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211555-003	BACLOFEN	5MG	TABLET / ORAL	BX	2021-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211555-001	BACLOFEN	10MG	TABLET / ORAL	BX	2019-02-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211555-002	BACLOFEN	20MG	TABLET / ORAL	BX	2019-02-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211555-003	BACLOFEN	5MG	TABLET / ORAL	BX	2021-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211555-001	BACLOFEN	10MG	TABLET / ORAL	BX	2019-02-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211555-002	BACLOFEN	20MG	TABLET / ORAL	BX	2019-02-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211555-003	BACLOFEN	5MG	TABLET / ORAL	BX	2021-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211555-001	BACLOFEN	10MG	TABLET / ORAL	BX	2019-02-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211555-002	BACLOFEN	20MG	TABLET / ORAL	BX	2019-02-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211555-003	BACLOFEN	5MG	TABLET / ORAL	BX	2021-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211555-001	BACLOFEN	10MG	TABLET / ORAL	BX	2019-02-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211555-002	BACLOFEN	20MG	TABLET / ORAL	BX	2019-02-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211555-003	BACLOFEN	5MG	TABLET / ORAL	BX	2021-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211555-001	BACLOFEN	10MG	TABLET / ORAL	BX	2019-02-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211555-002	BACLOFEN	20MG	TABLET / ORAL	BX	2019-02-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211555-003	BACLOFEN	5MG	TABLET / ORAL	BX	2021-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211555-001	BACLOFEN	10MG	TABLET / ORAL	BX	2019-02-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211555-002	BACLOFEN	20MG	TABLET / ORAL	BX	2019-02-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211555-003	BACLOFEN	5MG	TABLET / ORAL	BX	2021-11-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211555-001	BACLOFEN	10MG	TABLET / ORAL	BX	2019-02-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211555-002	BACLOFEN	20MG	TABLET / ORAL	BX	2019-02-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211555-003	BACLOFEN	5MG	TABLET / ORAL	BX	2021-11-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211555-001	BACLOFEN	10MG	TABLET / ORAL	BX	2019-02-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211555-002	BACLOFEN	20MG	TABLET / ORAL	BX	2019-02-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211555-003	BACLOFEN	5MG	TABLET / ORAL	BX	2021-11-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211555-001	BACLOFEN	10MG	TABLET / ORAL	BX	2019-02-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211555-002	BACLOFEN	20MG	TABLET / ORAL	BX	2019-02-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211555-003	BACLOFEN	5MG	TABLET / ORAL	BX	2021-11-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211555-001	BACLOFEN	10MG	TABLET / ORAL	BX	2019-02-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211555-002	BACLOFEN	20MG	TABLET / ORAL	BX	2019-02-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211555-003	BACLOFEN	5MG	TABLET / ORAL	BX	2021-11-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211555-001	BACLOFEN	10MG	TABLET / ORAL	AB	2019-02-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211555-002	BACLOFEN	20MG	TABLET / ORAL	AB	2019-02-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211555-003	BACLOFEN	5MG	TABLET / ORAL	AB	2021-11-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211555-001	BACLOFEN	10MG	TABLET / ORAL	AB	2019-02-01	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 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	A211555-001	BX	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211555-002	BX	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211555-003	BX	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211555-001	BX	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211555-002	BX	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211555-003	BX	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211555-001	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211555-002	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211555-003	BX	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211555-001	BX	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211555-002	BX	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211555-003	BX	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211555-001	BX	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211555-002	BX	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211555-003	BX	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211555-001	BX	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211555-002	BX	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211555-003	BX	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211555-001	BX	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211555-002	BX	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211555-003	BX	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211555-001	BX	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211555-002	BX	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211555-003	BX	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211555-001	BX	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211555-002	BX	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211555-003	BX	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211555-001	BX	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211555-002	BX	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211555-003	BX	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211555-001	BX	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211555-002	BX	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211555-003	BX	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211555-001	BX	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211555-002	BX	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211555-003	BX	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211555-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211555-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211555-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211555-001	AB	1	`8072bd15b7f6…`

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	Eywa Pharma Inc	7ec59f6b-7c4f-432d-ba27-442861806b6c	2026-05-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211555 application number: ANDA211555 ndc (product): 71930-007 ndc (product): 71930-066 ndc (product): 71930-006
Baclofen	BACLOFEN	NuCare Pharmaceuticals,Inc.	b2be2e6c-a247-30f4-e053-2a95a90a6ccb	2024-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211555 application number: ANDA211555 ndc (product): 68071-2289

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 36 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50436-0060	Baclofen	Baclofen	Unit Dose Services	ANDA	Current
60687-503	Baclofen	Baclofen	American Health Packaging	ANDA	Current
60687-503	Baclofen	Baclofen	American Health Packaging	ANDA	Current
60687-503	Baclofen	Baclofen	American Health Packaging	ANDA	Current
60687-514	Baclofen	Baclofen	American Health Packaging	ANDA	Current
60687-514	Baclofen	Baclofen	American Health Packaging	ANDA	Current
60687-514	Baclofen	Baclofen	American Health Packaging	ANDA	Current
68071-2289	Baclofen	Baclofen	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2289	Baclofen	Baclofen	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5252	Baclofen	Baclofen	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5252	Baclofen	Baclofen	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7635	Baclofen	Baclofen	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7635	Baclofen	Baclofen	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7643	Baclofen	Baclofen	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7643	Baclofen	Baclofen	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-2662	Baclofen	Baclofen	REMEDYREPACK INC.	ANDA	Current
70518-2662	Baclofen	Baclofen	REMEDYREPACK INC.	ANDA	Current
70518-2662	Baclofen	Baclofen	REMEDYREPACK INC.	ANDA	Current
70518-2804	Baclofen	Baclofen	REMEDYREPACK INC.	ANDA	Current
70518-2804	Baclofen	Baclofen	REMEDYREPACK INC.	ANDA	Current
71335-1643	Baclofen	Baclofen	Bryant Ranch Prepack	ANDA	Current
71335-1643	Baclofen	Baclofen	Bryant Ranch Prepack	ANDA	Current
71335-1643	Baclofen	Baclofen	Bryant Ranch Prepack	ANDA	Current
71335-1664	Baclofen	Baclofen	Bryant Ranch Prepack	ANDA	Current
71335-1664	Baclofen	Baclofen	Bryant Ranch Prepack	ANDA	Current
71335-1664	Baclofen	Baclofen	Bryant Ranch Prepack	ANDA	Current
71930-006	Baclofen	Baclofen	Eywa Pharma Inc	ANDA	Current
71930-006	Baclofen	Baclofen	Eywa Pharma Inc	ANDA	Current
71930-006	Baclofen	Baclofen	Eywa Pharma Inc	ANDA	Current
71930-006	Baclofen	Baclofen	Eywa Pharma Inc	ANDA	Current
71930-007	Baclofen	Baclofen	Eywa Pharma Inc	ANDA	Current
71930-007	Baclofen	Baclofen	Eywa Pharma Inc	ANDA	Current
71930-007	Baclofen	Baclofen	Eywa Pharma Inc	ANDA	Current
71930-007	Baclofen	Baclofen	Eywa Pharma Inc	ANDA	Current
71930-066	Baclofen	Baclofen	Eywa Pharma Inc	ANDA	Current
80175-0006	Baclofen	Baclofen	Central Packaging	ANDA	Current