Application 021589

Type: NDA
Sponsor: UCB INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KEMSTRO	BACLOFEN	TABLET, ORALLY DISINTEGRATING;ORAL	10MG	No	No
002	KEMSTRO	BACLOFEN	TABLET, ORALLY DISINTEGRATING;ORAL	20MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N021589-001	KEMSTRO	BACLOFEN	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2003-10-30
N021589-002	KEMSTRO	BACLOFEN	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2003-10-30

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021589-001	KEMSTRO	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		2003-10-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021589-002	KEMSTRO	20MG	TABLET, ORALLY DISINTEGRATING / ORAL		2003-10-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021589-001	KEMSTRO	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-10-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021589-002	KEMSTRO	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-10-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021589-001	KEMSTRO	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-10-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021589-002	KEMSTRO	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-10-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021589-001	KEMSTRO	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		2003-10-30	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021589-002	KEMSTRO	20MG	TABLET, ORALLY DISINTEGRATING / ORAL		2003-10-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021589-001	KEMSTRO	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		2003-10-30	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021589-002	KEMSTRO	20MG	TABLET, ORALLY DISINTEGRATING / ORAL		2003-10-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021589-001	KEMSTRO	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		2003-10-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021589-002	KEMSTRO	20MG	TABLET, ORALLY DISINTEGRATING / ORAL		2003-10-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021589-001	KEMSTRO	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		2003-10-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021589-002	KEMSTRO	20MG	TABLET, ORALLY DISINTEGRATING / ORAL		2003-10-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021589-001	KEMSTRO	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		2003-10-30	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021589-002	KEMSTRO	20MG	TABLET, ORALLY DISINTEGRATING / ORAL		2003-10-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021589-001	KEMSTRO	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		2003-10-30	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021589-002	KEMSTRO	20MG	TABLET, ORALLY DISINTEGRATING / ORAL		2003-10-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021589-001	KEMSTRO	10MG	TABLET, ORALLY DISINTEGRATING / ORAL		2003-10-30	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021589-002	KEMSTRO	20MG	TABLET, ORALLY DISINTEGRATING / ORAL		2003-10-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021589-001	KEMSTRO	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-10-30	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021589-002	KEMSTRO	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-10-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021589-001	KEMSTRO	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-10-30	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N021589-002	KEMSTRO	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-10-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021589-001	KEMSTRO	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-10-30	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021589-002	KEMSTRO	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-10-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021589-001	KEMSTRO	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-10-30	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021589-002	KEMSTRO	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-10-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021589-001	KEMSTRO	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-10-30	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021589-002	KEMSTRO	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-10-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021589-001	KEMSTRO	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-10-30	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021589-002	KEMSTRO	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-10-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021589-001	KEMSTRO	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-10-30	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021589-002	KEMSTRO	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-10-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021589-001	KEMSTRO	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-10-30	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N021589-002	KEMSTRO	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-10-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021589-001	KEMSTRO	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-10-30	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N021589-002	KEMSTRO	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-10-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021589-001	KEMSTRO	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-10-30	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021589-002	KEMSTRO	20MG	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-10-30	`3a93d1ddd44b…`

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

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
21750	ORIG	2006-07-25
37294	ORIG	2003-11-05
28199	ORIG	2003-11-05