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| N021589-001 | KEMSTRO | BACLOFEN | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2003-10-30 | |
| N021589-002 | KEMSTRO | BACLOFEN | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2003-10-30 |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| 2026-08 | N021589-001 | KEMSTRO | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2003-10-30 | 84e616aacf4f… | |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| 2026-08 | N021589-002 | KEMSTRO | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2003-10-30 | 84e616aacf4f… | |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| 2026-07 | N021589-001 | KEMSTRO | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2003-10-30 | caaa826d4ba7… | |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| 2026-07 | N021589-002 | KEMSTRO | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2003-10-30 | caaa826d4ba7… | |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 | Advagen Pharma Ltd | 2a43830f-a28b-ca15-e063-6294a90a6b1a | 2025-06-12 | Warnings, Adverse reactions | BACLOFEN |
| BACLOFEN | BACLOFEN | HAWAII REPACK, INC. | bc48a775-1feb-44c4-9453-e1ccf3d929bd | 2025-06-11 | Warnings, Adverse reactions | BACLOFEN |
| Baclofen | BACLOFEN | Advagen Pharma Ltd., | 75ab298b-b2a7-458f-accc-5bfc89b89a16 | 2025-06-11 | Warnings, Adverse reactions | BACLOFEN |
| BACLOFEN | BACLOFEN | Aurobindo Pharma Limited | 4679a275-9307-4b0f-a2eb-2d83227ea84d | 2025-06-11 | Warnings, Adverse reactions | BACLOFEN |
| Baclofen | BACLOFEN | Sagent Pharmaceuticals | d4bfba33-9f4d-4c43-ae6c-bcf67ef8fe51 | 2025-05-05 | Boxed warning, Warnings, Adverse reactions | BACLOFEN |
| BACLOFEN | BACLOFEN | Proficient Rx LP | 0243dd97-1d40-48f7-8853-76e046c605f2 | 2025-04-01 | Warnings, Adverse reactions | BACLOFEN |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 8cb96e7b-9c40-46a9-b964-7a573b7a0342 | 2025-02-21 | Warnings, Adverse reactions | BACLOFEN |
| BACLOFEN | BACLOFEN | XLCare Pharmaceuticals Inc. | 2b4908fb-47b5-4675-be9e-ca1ad48a7252 | 2025-02-05 | Warnings, Adverse reactions | BACLOFEN |
| BACLOFEN | BACLOFEN | NuCare Pharmaceuticals,Inc. | fd00fa8f-2797-c3f0-e053-6294a90a975f | 2025-02-05 | Warnings, Adverse reactions | BACLOFEN |
| BACLOFEN | BACLOFEN | Advanced Rx of Tennessee, LLC | 2cf71f5f-6d46-7506-e063-6294a90a186f | 2025-01-30 | Warnings, Adverse reactions | BACLOFEN |
| Baclofen | BACLOFEN | Direct_Rx | 020632f4-5e8a-f4a0-e063-6294a90a6301 | 2025-01-28 | Warnings, Adverse reactions | BACLOFEN |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 4b215bc5-f7f9-4b39-b8ee-42b233ee4aa2 | 2025-01-22 | Warnings, Adverse reactions | BACLOFEN |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 9bbcbf20-57ed-447b-9744-a5f10b9a057a | 2025-01-22 | Warnings, Adverse reactions | BACLOFEN |
| BACLOFEN | BACLOFEN | Asclemed USA, Inc. | 687f48da-bc41-4700-9513-77a32fc86c93 | 2025-01-15 | Warnings, Adverse reactions | BACLOFEN |
| BACLOFEN | BACLOFEN | Nexus Pharmaceuticals LLC | 68c9ade0-d783-43e9-8a3f-a16ec1501ec1 | 2025-01-02 | Boxed warning, Warnings, Adverse reactions | BACLOFEN |
| Baclofen | BACLOFEN | Advanced Rx of Tennessee, LLC | b33c534d-4fa3-0a2f-e053-2995a90ab52f | 2024-12-31 | Warnings, Adverse reactions | BACLOFEN |
| Baclofen | BACLOFEN | Advanced Rx of Tennessee, LLC | b33c4164-e607-2e27-e053-2a95a90ad7db | 2024-12-31 | Warnings, Adverse reactions | BACLOFEN |
| Baclofen | BACLOFEN | Advanced Rx Pharmacy of Tennessee, LLC | b4f2f888-979a-6f54-e053-2a95a90a95a3 | 2024-12-31 | Warnings, Adverse reactions | BACLOFEN |
| Baclofen | BACLOFEN | Advanced Rx Pharmacy of Tennessee, LLC | c85a1884-f46f-5cd4-e053-2a95a90a3e27 | 2024-12-31 | Warnings, Adverse reactions | BACLOFEN |
| Baclofen | BACLOFEN | Advanced Rx Pharmacy of Tennessee, LLC | c85a9d82-1d61-aeec-e053-2995a90a03a4 | 2024-12-31 | Warnings, Adverse reactions | BACLOFEN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.