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 5 of 9 · 168 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BACLOFEN	BACLOFEN	Advagen Pharma Ltd	2a43830f-a28b-ca15-e063-6294a90a6b1a	2025-06-12	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
BACLOFEN	BACLOFEN	HAWAII REPACK, INC.	bc48a775-1feb-44c4-9453-e1ccf3d929bd	2025-06-11	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
Baclofen	BACLOFEN	Advagen Pharma Ltd.,	75ab298b-b2a7-458f-accc-5bfc89b89a16	2025-06-11	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
BACLOFEN	BACLOFEN	Aurobindo Pharma Limited	4679a275-9307-4b0f-a2eb-2d83227ea84d	2025-06-11	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
Baclofen	BACLOFEN	Sagent Pharmaceuticals	d4bfba33-9f4d-4c43-ae6c-bcf67ef8fe51	2025-05-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
BACLOFEN	BACLOFEN	Proficient Rx LP	0243dd97-1d40-48f7-8853-76e046c605f2	2025-04-01	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
Baclofen	BACLOFEN	Bryant Ranch Prepack	8cb96e7b-9c40-46a9-b964-7a573b7a0342	2025-02-21	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
BACLOFEN	BACLOFEN	XLCare Pharmaceuticals Inc.	2b4908fb-47b5-4675-be9e-ca1ad48a7252	2025-02-05	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
BACLOFEN	BACLOFEN	NuCare Pharmaceuticals,Inc.	fd00fa8f-2797-c3f0-e053-6294a90a975f	2025-02-05	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
BACLOFEN	BACLOFEN	Advanced Rx of Tennessee, LLC	2cf71f5f-6d46-7506-e063-6294a90a186f	2025-01-30	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
Baclofen	BACLOFEN	Direct_Rx	020632f4-5e8a-f4a0-e063-6294a90a6301	2025-01-28	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Bryant Ranch Prepack	4b215bc5-f7f9-4b39-b8ee-42b233ee4aa2	2025-01-22	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Bryant Ranch Prepack	9bbcbf20-57ed-447b-9744-a5f10b9a057a	2025-01-22	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
BACLOFEN	BACLOFEN	Asclemed USA, Inc.	687f48da-bc41-4700-9513-77a32fc86c93	2025-01-15	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
BACLOFEN	BACLOFEN	Nexus Pharmaceuticals LLC	68c9ade0-d783-43e9-8a3f-a16ec1501ec1	2025-01-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
Baclofen	BACLOFEN	Advanced Rx of Tennessee, LLC	b33c534d-4fa3-0a2f-e053-2995a90ab52f	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Advanced Rx of Tennessee, LLC	b33c4164-e607-2e27-e053-2a95a90ad7db	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Advanced Rx Pharmacy of Tennessee, LLC	b4f2f888-979a-6f54-e053-2a95a90a95a3	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Advanced Rx Pharmacy of Tennessee, LLC	c85a1884-f46f-5cd4-e053-2a95a90a3e27	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Advanced Rx Pharmacy of Tennessee, LLC	c85a9d82-1d61-aeec-e053-2995a90a03a4	2024-12-31	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