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| N021589-001 | KEMSTRO | BACLOFEN | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2003-10-30 | |
| N021589-002 | KEMSTRO | BACLOFEN | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2003-10-30 |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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 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UTC | 2026-02 | N021589-001 | KEMSTRO | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2003-10-30 | 011fe1cb6892… | |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UTC | 2026-02 | N021589-002 | KEMSTRO | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2003-10-30 | 011fe1cb6892… | |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this ZIP | 2025-12 | N021589-001 | KEMSTRO | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2003-10-30 | 31067a03dcf5… | |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… | ||
| 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… |
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 | Cardinal Health 107, LLC | 3c87e116-871d-46b8-897b-fc27a17b988d | 2026-07-24 | Warnings, Adverse reactions | BACLOFEN |
| Baclofen | BACLOFEN | Preferred Pharmaceuticals Inc. | 3047613d-006b-4011-b5fe-098588f474aa | 2026-07-22 | Warnings, Adverse reactions | BACLOFEN |
| Baclofen | BACLOFEN | REMEDYREPACK INC. | 6274e70a-fb57-461b-b1bc-39d4ff916b2a | 2026-07-14 | Warnings, Adverse reactions | BACLOFEN |
| Baclofen | BACLOFEN | Atlantic Biologicals Corp. | 50b3e7be-832b-313d-e063-6394a90a5ab4 | 2026-07-14 | Warnings, Adverse reactions | BACLOFEN |
| Baclofen | BACLOFEN | REMEDYREPACK INC. | ebbfec9e-621c-4d04-8a1c-81d2eb9e9c74 | 2026-06-30 | Warnings, Adverse reactions | BACLOFEN |
| Baclofen | BACLOFEN | AvPAK | c21095a9-17b1-555a-e053-2a95a90a51fd | 2026-06-29 | Warnings, Adverse reactions | BACLOFEN |
| BACLOFEN | BACLOFEN | NuCare Pharmaceuticals, Inc. | 2517f71f-f452-1f56-e063-6394a90a6ef1 | 2026-06-25 | Warnings, Adverse reactions | BACLOFEN |
| BACLOFEN | BACLOFEN | Redpharm Drug | 53df4b4b-842e-9e3a-e063-6394a90a8a3d | 2026-06-10 | Warnings, Adverse reactions | BACLOFEN |
| Baclofen | BACLOFEN | REMEDYREPACK INC. | d689d32c-12a7-4ae4-afc3-8a353be67148 | 2026-06-01 | Warnings, Adverse reactions | BACLOFEN |
| Baclofen | BACLOFEN | Eywa Pharma Inc | 7ec59f6b-7c4f-432d-ba27-442861806b6c | 2026-05-16 | Warnings, Adverse reactions | BACLOFEN |
| BACLOFEN | BACLOFEN | REMEDYREPACK INC. | e017a001-8cb1-4dd8-960e-c6d74005f57f | 2026-05-12 | Warnings, Adverse reactions | BACLOFEN |
| Baclofen | BACLOFEN | AvPAK | bc9040d9-1c54-9d62-e053-2a95a90a6ae3 | 2026-05-06 | Warnings, Adverse reactions | BACLOFEN |
| Baclofen | BACLOFEN | Coupler LLC | 5023c690-fd86-bb7d-e063-6394a90af6cd | 2026-04-23 | Warnings, Adverse reactions | BACLOFEN |
| Baclofen | BACLOFEN | Cardinal Health 107, LLC | 2278954a-7605-426a-ae85-1bf0a3117420 | 2026-04-22 | Warnings, Adverse reactions | BACLOFEN |
| Baclofen | BACLOFEN | Golden State Medical Supply, Inc. | 32336e92-89a4-7d7f-e063-6394a90ae924 | 2026-04-21 | Warnings, Adverse reactions | BACLOFEN |
| BACLOFEN | BACLOFEN | REMEDYREPACK INC. | ac9b720f-b755-49f1-9850-efb26feadaeb | 2026-04-14 | Warnings, Adverse reactions | BACLOFEN |
| BACLOFEN | BACLOFEN | Cardinal Health 107, LLC | a0cdf5e0-45cb-41e0-a6f1-6e3aaf02b67c | 2026-04-13 | Warnings, Adverse reactions | BACLOFEN |
| BACLOFEN | BACLOFEN | REMEDYREPACK INC. | 355266e4-68f7-47d7-9f4e-1a0fc912786d | 2026-04-10 | Warnings, Adverse reactions | BACLOFEN |
| BACLOFEN | BACLOFEN | Medcore LLC | 13eca70c-3cc8-4317-83cf-ade3327e48c0 | 2026-04-01 | Warnings, Adverse reactions | BACLOFEN |
| Baclofen | BACLOFEN | Rosemont Pharmaceuticals LLC | 81a539b3-e547-4a62-ad1b-2eedb30be927 | 2026-03-30 | Warnings, Adverse reactions | BACLOFEN |