Application 210048

Type: ANDA
Sponsor: MAIA PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BACLOFEN	BACLOFEN	INJECTABLE;INTRATHECAL	0.5MG/ML	No	No
002	BACLOFEN	BACLOFEN	INJECTABLE;INTRATHECAL	2MG/ML	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
A210048-001	BACLOFEN	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP		2019-09-11
A210048-002	BACLOFEN	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP		2019-09-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210048-001	AP
A210048-002	AP

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 · 80 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	A210048-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210048-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210048-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210048-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210048-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210048-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210048-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210048-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210048-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210048-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210048-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210048-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210048-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210048-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210048-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210048-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210048-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210048-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210048-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210048-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210048-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210048-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210048-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210048-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210048-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210048-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210048-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210048-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210048-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210048-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210048-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210048-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210048-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210048-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210048-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210048-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210048-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210048-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210048-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210048-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2019-09-11	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 72 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	A210048-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210048-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210048-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210048-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210048-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210048-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210048-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210048-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210048-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210048-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210048-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210048-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210048-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210048-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210048-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210048-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210048-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210048-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210048-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210048-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210048-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210048-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210048-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210048-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210048-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210048-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210048-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210048-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210048-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210048-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210048-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210048-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210048-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210048-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210048-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210048-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210048-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210048-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210048-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210048-002	AP	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Baclofen (Intrathecal)	BACLOFEN	MAIA Pharmaceuticals, Inc.	11ba5575-a856-414a-89f8-17f3a01de55b	2023-11-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210048 application number: ANDA210048 ndc (product): 70511-124 ndc (product): 70511-122
Baclofen	BACLOFEN	Sagent Pharmaceuticals	077aaf3b-1ca3-4599-a51a-6bbe39810ca8	2021-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210048 application number: ANDA210048 ndc (product): 25021-678 ndc (product): 25021-679

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
25021-678	Baclofen	Baclofen	Sagent Pharmaceuticals	ANDA	Current
25021-679	Baclofen	Baclofen	Sagent Pharmaceuticals	ANDA	Current
70511-122	Baclofen (Intrathecal)	baclofen	MAlA Pharmaceuticals, Inc.	ANDA	Current
70511-124	Baclofen (Intrathecal)	baclofen	MAlA Pharmaceuticals, Inc.	ANDA	Current