Application 021589
- Type
- NDA
- Sponsor
- UCB INC
Application Products#
| 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 |
Orange Book products#
| 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| N021589-001 | KEMSTRO | BACLOFEN | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2003-10-30 | |
| N021589-002 | KEMSTRO | BACLOFEN | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2003-10-30 |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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N021589-001 | KEMSTRO | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2003-10-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N021589-002 | KEMSTRO | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2003-10-30 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N021589-001 | KEMSTRO | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2003-10-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N021589-002 | KEMSTRO | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2003-10-30 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021589-001 | KEMSTRO | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2003-10-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021589-002 | KEMSTRO | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2003-10-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021589-001 | KEMSTRO | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2003-10-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021589-002 | KEMSTRO | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2003-10-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021589-001 | KEMSTRO | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2003-10-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021589-002 | KEMSTRO | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2003-10-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021589-001 | KEMSTRO | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2003-10-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021589-002 | KEMSTRO | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2003-10-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021589-001 | KEMSTRO | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2003-10-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021589-002 | KEMSTRO | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2003-10-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021589-001 | KEMSTRO | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2003-10-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021589-002 | KEMSTRO | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2003-10-30 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021589-001 | KEMSTRO | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2003-10-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021589-002 | KEMSTRO | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2003-10-30 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021589-001 | KEMSTRO | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2003-10-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021589-002 | KEMSTRO | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2003-10-30 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021589-001 | KEMSTRO | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2003-10-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021589-002 | KEMSTRO | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2003-10-30 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021589-001 | KEMSTRO | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2003-10-30 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021589-002 | KEMSTRO | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2003-10-30 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021589-001 | KEMSTRO | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2003-10-30 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021589-002 | KEMSTRO | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2003-10-30 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021589-001 | KEMSTRO | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2003-10-30 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021589-002 | KEMSTRO | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2003-10-30 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021589-001 | KEMSTRO | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2003-10-30 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021589-002 | KEMSTRO | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2003-10-30 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021589-001 | KEMSTRO | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2003-10-30 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021589-002 | KEMSTRO | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2003-10-30 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021589-001 | KEMSTRO | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2003-10-30 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021589-002 | KEMSTRO | 20MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2003-10-30 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021589-001 | KEMSTRO | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2003-10-30 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021589-002 | KEMSTRO | 20MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2003-10-30 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021589-001 | KEMSTRO | 10MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2003-10-30 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021589-002 | KEMSTRO | 20MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2003-10-30 | 4b0b4de00fa7… | |
| 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… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 80b0a41e-2cad-4e14-9605-0cd35f9991e9 | 2026-02-05 | Warnings, Adverse reactions | BACLOFEN |
| BACLOFEN | BACLOFEN | Bryant Ranch Prepack | 7df6e691-f1d5-441c-b5bb-a3867983e09f | 2026-02-05 | Warnings, Adverse reactions | BACLOFEN |
| Baclofen | BACLOFEN | Preferred Pharmaceuticals, Inc. | 58416ceb-994f-4571-afbd-c2171823f528 | 2026-01-26 | Warnings, Adverse reactions | BACLOFEN |
| BACLOFEN | BACLOFEN | Advagen Pharma Limited | 04dac0f6-cc6c-4959-9bca-a6e4a99690f3 | 2026-01-23 | Warnings, Adverse reactions | BACLOFEN |
| Baclofen | BACLOFEN | Preferred Pharmaceuticals Inc. | 69d0027a-cb46-4754-9225-071ec1ce4b37 | 2026-01-21 | Warnings, Adverse reactions | BACLOFEN |
| Baclofen | BACLOFEN | A-S Medication Solutions | 975fda6d-d929-482b-8be7-60849026dbdd | 2026-01-20 | Warnings, Adverse reactions | BACLOFEN |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 808113db-c5c2-404c-ab5f-62b991641cfe | 2026-01-12 | Warnings, Adverse reactions | BACLOFEN |
| Baclofen | BACLOFEN | Major Pharmaceuticals | ae732bdc-5178-4565-8219-d1787a5211a6 | 2026-01-09 | Warnings, Adverse reactions | BACLOFEN |
| Baclofen | BACLOFEN | Palmetto Pharmaceuticals Inc. | 2422746c-afec-ad30-e063-6394a90a0403 | 2025-12-31 | Warnings, Adverse reactions | BACLOFEN |
| Baclofen | BACLOFEN | Northwind Health Company, LLC | 06bcfb08-2ada-f803-e063-6394a90a826b | 2025-12-26 | Warnings, Adverse reactions | BACLOFEN |
| BACLOFEN | BACLOFEN | Advanced Rx of Tennessee, LLC | 459ec5f5-4f99-e917-e063-6294a90a23cd | 2025-12-18 | Warnings, Adverse reactions | BACLOFEN |
| Baclofen | BACLOFEN | Wilshire Pharmaceuticals, Inc. | 4585aafe-0af8-4786-a419-6a7e76671ca2 | 2025-12-16 | Warnings, Adverse reactions | BACLOFEN |
| FLEQSUVY | BACLOFEN | Azurity Pharmaceuticals, Inc. | 9076d6ce-bbc2-4a9f-9cb9-2de1b675b9aa | 2025-12-16 | Warnings, Adverse reactions | BACLOFEN |
| Baclofen | BACLOFEN | PHOENIX RX LLC | 45c6d45d-95d5-21b8-e063-6294a90a7955 | 2025-12-12 | Warnings, Adverse reactions | BACLOFEN |
| Baclofen | BACLOFEN | Upsher-Smith Laboratories, LLC | b2747a9d-5fca-4657-9e4b-4112607f30d8 | 2025-12-11 | Warnings, Adverse reactions | BACLOFEN |
| BACLOFEN | BACLOFEN | Advagen Pharma Limited | d63af5f0-c275-480b-89b5-6cf1ad55ab63 | 2025-12-09 | Boxed warning, Warnings, Adverse reactions | BACLOFEN |
| BACLOFEN | BACLOFEN | SOLA Pharmaceuticals, LLC | 7b308b35-8c08-458d-860e-c78d057e8260 | 2025-12-08 | Warnings, Adverse reactions | BACLOFEN |
| Baclofen | BACLOFEN | ANI Pharmaceuticals, Inc. | c73ed3af-8e8a-4a18-90fc-a0f2dcc641d0 | 2025-12-04 | Warnings, Adverse reactions | BACLOFEN |
| BACLOFEN | BACLOFEN | Proficient Rx LP | 0680301a-1649-46c4-b74e-ab03967945d0 | 2025-12-01 | Warnings, Adverse reactions | BACLOFEN |
| BACLOFEN | BACLOFEN | Aurobindo Pharma Limited | f4e8cbc5-b1f2-4331-a267-d5bd90bcde8a | 2025-11-24 | Warnings, Adverse reactions | BACLOFEN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.