Application 209592

Type: ANDA
Sponsor: MYLAN LABS LTD

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 43.

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
A209592-001	BACLOFEN	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP		2018-03-21
A209592-002	BACLOFEN	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP		2018-03-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209592-001	AP
A209592-002	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 3 · 86 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
2026-09-14 22:38:34	2026-08	A209592-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2018-03-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209592-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2018-03-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209592-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2018-03-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209592-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2018-03-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209592-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2018-03-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209592-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2018-03-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209592-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2018-03-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209592-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2018-03-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209592-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2018-03-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209592-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2018-03-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209592-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2018-03-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209592-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2018-03-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209592-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2018-03-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209592-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2018-03-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209592-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2018-03-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209592-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2018-03-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209592-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2018-03-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209592-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2018-03-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209592-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2018-03-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209592-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2018-03-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209592-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2018-03-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209592-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2018-03-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209592-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2018-03-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209592-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2018-03-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209592-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2018-03-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209592-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2018-03-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209592-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2018-03-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209592-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2018-03-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209592-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2018-03-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209592-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2018-03-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209592-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2018-03-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209592-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2018-03-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209592-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2018-03-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209592-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2018-03-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209592-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2018-03-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209592-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2018-03-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209592-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2018-03-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209592-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2018-03-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209592-001	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2018-03-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209592-002	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2018-03-21	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A209592-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209592-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209592-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209592-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209592-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209592-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209592-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209592-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209592-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209592-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209592-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209592-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209592-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209592-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209592-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209592-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209592-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209592-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209592-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209592-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209592-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209592-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209592-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209592-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209592-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209592-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209592-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209592-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209592-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209592-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209592-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209592-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209592-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209592-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209592-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209592-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209592-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209592-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209592-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209592-002	AP	1	`74a2ff9319b5…`

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 2 of 9 · 168 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Baclofen	BACLOFEN	Coupler LLC	5023c690-fd86-bb7d-e063-6394a90af6cd	2026-04-23	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Cardinal Health 107, LLC	2278954a-7605-426a-ae85-1bf0a3117420	2026-04-22	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Golden State Medical Supply, Inc.	32336e92-89a4-7d7f-e063-6394a90ae924	2026-04-21	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
BACLOFEN	BACLOFEN	Cardinal Health 107, LLC	a0cdf5e0-45cb-41e0-a6f1-6e3aaf02b67c	2026-04-13	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
BACLOFEN	BACLOFEN	Medcore LLC	13eca70c-3cc8-4317-83cf-ade3327e48c0	2026-04-01	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
BACLOFEN	BACLOFEN	PD-Rx Pharmaceuticals, Inc.	ee59a379-17d5-487f-b72f-a53e74744a70	2026-03-27	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
BACLOFEN	BACLOFEN	PD-Rx Pharmaceuticals, Inc.	91175128-8285-4d04-89a9-219781be9260	2026-03-25	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
BACLOFEN	BACLOFEN	PD-Rx Pharmaceuticals, Inc.	16266972-843e-4ea5-be1f-fb1b1588a5dc	2026-03-25	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
BACLOFEN	BACLOFEN	PD-Rx Pharmaceuticals, Inc.	0a1d09ac-94d5-45ef-92cc-bc261c2b2d75	2026-03-25	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
Baclofen	BACLOFEN	A-S Medication Solutions	4f84b27a-725a-48e6-a58a-85bbb395f4ae	2026-03-23	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
BACLOFEN	BACLOFEN	Preferred Pharmaceuticals Inc.	d20cc8b2-5236-4c87-b395-0acaaf7b62dd	2026-03-19	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
Baclofen	BACLOFEN	A-S Medication Solutions	5f6a86f9-9658-4210-a47c-62907edfd416	2026-03-19	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
BACLOFEN	BACLOFEN	Preferred Pharmaceuticals Inc.	9bd46eb6-53b2-4845-88b4-81c1ced08aaa	2026-03-19	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
BACLOFEN	BACLOFEN	Preferred Pharmaceuticals Inc.	5e479876-adfb-4590-ac10-3924ff7988b0	2026-03-18	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
BACLOFEN	BACLOFEN	Preferred Pharmaceuticals Inc.	3fdfeef9-68b3-4f6c-a4de-28179758a962	2026-03-18	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
Baclofen	BACLOFEN	Redpharm Drug	4ce1de84-72e1-57d3-e063-6294a90a220f	2026-03-13	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
OZOBAX DS	BACLOFEN	Rosemont Pharmaceuticals LLC	d8ddcec5-debe-42b4-a803-e65917cc6a54	2026-03-13	Warnings, Adverse reactions	Name fallback generic name: BACLOFEN
Baclofen	BACLOFEN	Lifestar Pharma LLC	f9dd1b55-2984-446a-8146-2ab0f5211e15	2026-02-27	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	A-S Medication Solutions	7ee42a29-21c2-47f8-a5b3-f3af115b665d	2026-02-24	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
BACLOFEN	BACLOFEN	Major Pharmaceuticals	46f84504-ffc4-4be5-9598-c20a3f4210f4	2026-02-13	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
67457-562	Baclofen	Baclofen	Mylan Institutional LLC	ANDA	Current
67457-562	Baclofen	Baclofen	Mylan Institutional LLC	ANDA	Current
67457-564	Baclofen	Baclofen	Mylan Institutional LLC	ANDA	Current
67457-564	Baclofen	Baclofen	Mylan Institutional LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
53498	ORIG	2018-03-28
53142	ORIG	2018-03-22