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 1 of 9 · 169 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BACLOFEN	BACLOFEN	REMEDYREPACK INC.	ab3760cd-a84b-49ba-88e3-b9ea73c55f82	2026-09-09	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
Baclofen	BACLOFEN	Atlantic Biologicals Corp.	50b3e7be-832b-313d-e063-6394a90a5ab4	2026-09-04	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
BACLOFEN	BACLOFEN	REMEDYREPACK INC.	4e2cd27d-91c7-4f15-96cc-3971769dbeaa	2026-09-03	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
BACLOFEN	BACLOFEN	REMEDYREPACK INC.	c2e1d183-7061-459b-a631-206b06d12753	2026-09-01	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
Baclofen	BACLOFEN	Par Health USA, LLC	c17527be-661d-42f5-b6f6-56a681ba7870	2026-08-24	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Bryant Ranch Prepack	aeb56b0e-7126-4417-b726-e8a54f73de3f	2026-08-24	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
BACLOFEN	BACLOFEN	REMEDYREPACK INC.	ac9b720f-b755-49f1-9850-efb26feadaeb	2026-08-14	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
BACLOFEN	BACLOFEN	REMEDYREPACK INC.	355266e4-68f7-47d7-9f4e-1a0fc912786d	2026-08-10	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
Baclofen	BACLOFEN	REMEDYREPACK INC.	76896b07-2835-4467-b386-87ec66ddd88e	2026-08-04	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Cardinal Health 107, LLC	3c87e116-871d-46b8-897b-fc27a17b988d	2026-07-24	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Preferred Pharmaceuticals Inc.	3047613d-006b-4011-b5fe-098588f474aa	2026-07-22	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	REMEDYREPACK INC.	6274e70a-fb57-461b-b1bc-39d4ff916b2a	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	REMEDYREPACK INC.	ebbfec9e-621c-4d04-8a1c-81d2eb9e9c74	2026-06-30	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	AvPAK	c21095a9-17b1-555a-e053-2a95a90a51fd	2026-06-29	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
BACLOFEN	BACLOFEN	NuCare Pharmaceuticals, Inc.	2517f71f-f452-1f56-e063-6394a90a6ef1	2026-06-25	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
BACLOFEN	BACLOFEN	Redpharm Drug	53df4b4b-842e-9e3a-e063-6394a90a8a3d	2026-06-10	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
Baclofen	BACLOFEN	REMEDYREPACK INC.	d689d32c-12a7-4ae4-afc3-8a353be67148	2026-06-01	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
Baclofen	BACLOFEN	Eywa Pharma Inc	7ec59f6b-7c4f-432d-ba27-442861806b6c	2026-05-16	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN
BACLOFEN	BACLOFEN	REMEDYREPACK INC.	e017a001-8cb1-4dd8-960e-c6d74005f57f	2026-05-12	Warnings, Adverse reactions	Name fallback brand name: BACLOFEN generic name: BACLOFEN
Baclofen	BACLOFEN	AvPAK	bc9040d9-1c54-9d62-e053-2a95a90a6ae3	2026-05-06	Warnings, Adverse reactions	Name fallback brand name: Baclofen generic name: BACLOFEN

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