Application 091193

Type: ANDA
Sponsor: EMERALD INTL LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BACLOFEN	BACLOFEN	INJECTABLE;INTRATHECAL	0.05MG/ML	No	No
002	BACLOFEN	BACLOFEN	INJECTABLE;INTRATHECAL	0.5MG/ML	No	No
003	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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A091193-001	BACLOFEN	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	2016-05-03
A091193-002	BACLOFEN	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2016-05-03
A091193-003	BACLOFEN	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2016-05-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091193-001	AP
A091193-002	AP
A091193-003	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 4 · 129 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	A091193-001	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	2016-05-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091193-002	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2016-05-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091193-003	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2016-05-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091193-001	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	2016-05-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091193-002	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2016-05-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091193-003	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2016-05-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091193-001	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	2016-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091193-002	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2016-05-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091193-003	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2016-05-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091193-001	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	2016-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091193-002	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2016-05-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091193-003	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2016-05-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091193-001	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	2016-05-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091193-002	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2016-05-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091193-003	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2016-05-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091193-001	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	2016-05-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091193-002	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2016-05-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091193-003	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2016-05-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091193-001	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	2016-05-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091193-002	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2016-05-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091193-003	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2016-05-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091193-001	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	2016-05-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091193-002	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2016-05-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091193-003	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2016-05-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091193-001	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	2016-05-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091193-002	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2016-05-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091193-003	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2016-05-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091193-001	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	2016-05-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091193-002	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2016-05-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091193-003	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2016-05-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091193-001	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	2016-05-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091193-002	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2016-05-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091193-003	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2016-05-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091193-001	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	2016-05-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091193-002	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2016-05-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091193-003	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2016-05-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091193-001	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	2016-05-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091193-002	BACLOFEN	0.5MG/ML	INJECTABLE / INTRATHECAL	AP	2016-05-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091193-003	BACLOFEN	2MG/ML	INJECTABLE / INTRATHECAL	AP	2016-05-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091193-001	BACLOFEN	0.05MG/ML	INJECTABLE / INTRATHECAL	AP	2016-05-03	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 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	A091193-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091193-002	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091193-003	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091193-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091193-002	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091193-003	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091193-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091193-002	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091193-003	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091193-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091193-002	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091193-003	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091193-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091193-002	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091193-003	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091193-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091193-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091193-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091193-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091193-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091193-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091193-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091193-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091193-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091193-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091193-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091193-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091193-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091193-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091193-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091193-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091193-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091193-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091193-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091193-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091193-003	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091193-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091193-002	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091193-003	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091193-001	AP	1	`301d65b070ca…`

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 6 of 9 · 168 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Baclofen	BACLOFEN	Advanced Rx Pharmacy of Tennessee, LLC	ec09736a-dd2b-0a3b-e053-2995a90a9542	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
BACLOFEN	BACLOFEN	Advanced Rx of Tennessee, LLC	2a58145a-57f9-6bb1-e063-6294a90a32a8	2024-12-29	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
BACLOFEN	BACLOFEN	Advanced Rx of Tennessee, LLC	2a586399-49e9-1e5c-e063-6294a90a4872	2024-12-28	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
Baclofen	BACLOFEN	Advanced Rx of Tennessee, LLC	29987a4c-cf5f-4f98-e063-6394a90a7f19	2024-12-19	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
BACLOFEN	BACLOFEN	Quality Care Products, LLC	67df80a6-7fff-496e-9a89-d43a06c2a11f	2024-12-19	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
Baclofen	BACLOFEN	Bryant Ranch Prepack	7b6d33d8-58c2-448d-a8df-1de7339b1520	2024-12-12	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Bryant Ranch Prepack	4cbb2264-ef65-4906-86e5-349deeeda7a9	2024-12-05	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Bryant Ranch Prepack	32525b4e-6384-49e1-a66d-abe45484ab86	2024-12-05	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Bryant Ranch Prepack	e13c0563-0f32-4199-acb0-ad2376ec951b	2024-12-05	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Bryant Ranch Prepack	43cafbdb-6927-45f6-9b16-3b125cc2a29d	2024-11-27	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Advanced Rx Pharmacy of Tennessee, LLC	f5edb656-4f7e-2386-e053-2995a90a70de	2024-11-15	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Chartwell RX, LLC	2a75db96-590a-43cf-aefb-3bbcb287dbf0	2024-10-10	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	NCS HealthCare of KY, LLC dba Vangard Labs	ea4ad5c5-207c-4a68-8e6e-4ff101777e5c	2024-10-04	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Proficient Rx LP	b981eb16-a195-41da-a186-3e91b63b2def	2024-10-01	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Proficient Rx LP	9d5a10cf-9a99-41eb-b4b8-9cf4cfaff6fc	2024-10-01	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
BACLOFEN	BACLOFEN	Bryant Ranch Prepack	f9c6d75a-a956-47b6-a5a2-deaf9797e2b2	2024-09-16	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
Baclofen	BACLOFEN	Bryant Ranch Prepack	08a6866f-b127-482f-9f22-113175487bdd	2024-09-12	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Bryant Ranch Prepack	5b92b0a6-ebba-4815-8b94-f2014674399b	2024-09-05	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Bryant Ranch Prepack	4634093b-6def-41d6-a7f3-23040125c4f4	2024-09-03	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Bryant Ranch Prepack	655db2a3-daf7-4f4b-8f64-4a6d81fdc165	2024-09-03	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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71525-005	Baclofen (intrathecal)	baclofen	Emerald International Limited	ANDA	Current
71525-010	Baclofen (intrathecal)	baclofen	Emerald International Limited	ANDA	Current
71525-040	Baclofen (intrathecal)	baclofen	Emerald International Limited	ANDA	Current