Application 017851
- Type
- NDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LIORESAL | BACLOFEN | TABLET;ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | LIORESAL | BACLOFEN | TABLET;ORAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N017851-001 | LIORESAL | BACLOFEN | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N017851-003 | LIORESAL | BACLOFEN | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1982-01-20 |
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| 2026-08 | N017851-001 | LIORESAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N017851-003 | LIORESAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1982-01-20 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N017851-001 | LIORESAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N017851-003 | LIORESAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1982-01-20 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N017851-001 | LIORESAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N017851-003 | LIORESAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1982-01-20 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017851-001 | LIORESAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017851-003 | LIORESAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1982-01-20 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N017851-001 | LIORESAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N017851-003 | LIORESAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1982-01-20 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017851-001 | LIORESAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017851-003 | LIORESAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1982-01-20 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017851-001 | LIORESAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017851-003 | LIORESAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1982-01-20 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017851-001 | LIORESAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017851-003 | LIORESAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1982-01-20 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017851-001 | LIORESAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017851-003 | LIORESAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1982-01-20 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017851-001 | LIORESAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017851-003 | LIORESAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1982-01-20 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N017851-001 | LIORESAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N017851-003 | LIORESAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1982-01-20 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N017851-001 | LIORESAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N017851-003 | LIORESAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1982-01-20 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N017851-001 | LIORESAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N017851-003 | LIORESAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1982-01-20 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N017851-001 | LIORESAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N017851-003 | LIORESAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1982-01-20 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N017851-001 | LIORESAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N017851-003 | LIORESAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1982-01-20 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N017851-001 | LIORESAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N017851-003 | LIORESAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1982-01-20 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N017851-001 | LIORESAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N017851-003 | LIORESAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1982-01-20 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N017851-001 | LIORESAL | 10MG | TABLET / ORAL | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N017851-003 | LIORESAL | 20MG | TABLET / ORAL | RLD | 1982-01-20 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N017851-001 | LIORESAL | 10MG | TABLET / ORAL | RLD, Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N017851-003 | LIORESAL | 20MG | TABLET / ORAL | RLD | 1982-01-20 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N017851-001 | LIORESAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD, Approved before 1982 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N017851-003 | LIORESAL | 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET / ORAL | RLD | 1982-01-20 | 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 | Advanced Rx Pharmacy of Tennessee, LLC | ec09736a-dd2b-0a3b-e053-2995a90a9542 | 2024-12-31 | Warnings, Adverse reactions | BACLOFEN |
| BACLOFEN | BACLOFEN | Advanced Rx of Tennessee, LLC | 2a58145a-57f9-6bb1-e063-6294a90a32a8 | 2024-12-29 | Warnings, Adverse reactions | BACLOFEN |
| BACLOFEN | BACLOFEN | Advanced Rx of Tennessee, LLC | 2a586399-49e9-1e5c-e063-6294a90a4872 | 2024-12-28 | Warnings, Adverse reactions | BACLOFEN |
| Baclofen | BACLOFEN | Advanced Rx of Tennessee, LLC | 29987a4c-cf5f-4f98-e063-6394a90a7f19 | 2024-12-19 | Warnings, Adverse reactions | BACLOFEN |
| BACLOFEN | BACLOFEN | Quality Care Products, LLC | 67df80a6-7fff-496e-9a89-d43a06c2a11f | 2024-12-19 | Warnings, Adverse reactions | BACLOFEN |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 7b6d33d8-58c2-448d-a8df-1de7339b1520 | 2024-12-12 | Warnings, Adverse reactions | BACLOFEN |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 4cbb2264-ef65-4906-86e5-349deeeda7a9 | 2024-12-05 | Warnings, Adverse reactions | BACLOFEN |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 32525b4e-6384-49e1-a66d-abe45484ab86 | 2024-12-05 | Warnings, Adverse reactions | BACLOFEN |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | e13c0563-0f32-4199-acb0-ad2376ec951b | 2024-12-05 | Warnings, Adverse reactions | BACLOFEN |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 43cafbdb-6927-45f6-9b16-3b125cc2a29d | 2024-11-27 | Warnings, Adverse reactions | BACLOFEN |
| Baclofen | BACLOFEN | Advanced Rx Pharmacy of Tennessee, LLC | f5edb656-4f7e-2386-e053-2995a90a70de | 2024-11-15 | Warnings, Adverse reactions | BACLOFEN |
| Baclofen | BACLOFEN | Chartwell RX, LLC | 2a75db96-590a-43cf-aefb-3bbcb287dbf0 | 2024-10-10 | Warnings, Adverse reactions | BACLOFEN |
| Baclofen | BACLOFEN | NCS HealthCare of KY, LLC dba Vangard Labs | ea4ad5c5-207c-4a68-8e6e-4ff101777e5c | 2024-10-04 | Warnings, Adverse reactions | BACLOFEN |
| Baclofen | BACLOFEN | Proficient Rx LP | b981eb16-a195-41da-a186-3e91b63b2def | 2024-10-01 | Warnings, Adverse reactions | BACLOFEN |
| Baclofen | BACLOFEN | Proficient Rx LP | 9d5a10cf-9a99-41eb-b4b8-9cf4cfaff6fc | 2024-10-01 | Warnings, Adverse reactions | BACLOFEN |
| BACLOFEN | BACLOFEN | Bryant Ranch Prepack | f9c6d75a-a956-47b6-a5a2-deaf9797e2b2 | 2024-09-16 | Warnings, Adverse reactions | BACLOFEN |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 08a6866f-b127-482f-9f22-113175487bdd | 2024-09-12 | Warnings, Adverse reactions | BACLOFEN |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 5b92b0a6-ebba-4815-8b94-f2014674399b | 2024-09-05 | Warnings, Adverse reactions | BACLOFEN |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 4634093b-6def-41d6-a7f3-23040125c4f4 | 2024-09-03 | Warnings, Adverse reactions | BACLOFEN |
| Baclofen | BACLOFEN | Bryant Ranch Prepack | 655db2a3-daf7-4f4b-8f64-4a6d81fdc165 | 2024-09-03 | Warnings, Adverse reactions | BACLOFEN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.