Application 019151
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RYTHMOL | PROPAFENONE HYDROCHLORIDE | TABLET;ORAL | 150MG | Yes | No |
| 002 | RYTHMOL | PROPAFENONE HYDROCHLORIDE | TABLET;ORAL | 300MG | Yes | No |
| 003 | RYTHMOL | PROPAFENONE HYDROCHLORIDE | TABLET;ORAL | 225MG | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019151-001 | RYTHMOL | PROPAFENONE HYDROCHLORIDE | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1989-11-27 | |
| N019151-002 | RYTHMOL | PROPAFENONE HYDROCHLORIDE | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1989-11-27 | |
| N019151-003 | RYTHMOL | PROPAFENONE HYDROCHLORIDE | 225MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1992-11-20 |
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| 2026-08 | N019151-001 | RYTHMOL | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1989-11-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N019151-002 | RYTHMOL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1989-11-27 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N019151-003 | RYTHMOL | 225MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1992-11-20 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N019151-001 | RYTHMOL | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1989-11-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019151-002 | RYTHMOL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1989-11-27 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N019151-003 | RYTHMOL | 225MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1992-11-20 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019151-001 | RYTHMOL | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1989-11-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019151-002 | RYTHMOL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1989-11-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019151-003 | RYTHMOL | 225MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1992-11-20 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019151-001 | RYTHMOL | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1989-11-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019151-002 | RYTHMOL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1989-11-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019151-003 | RYTHMOL | 225MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1992-11-20 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019151-001 | RYTHMOL | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1989-11-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019151-002 | RYTHMOL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1989-11-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019151-003 | RYTHMOL | 225MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1992-11-20 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019151-001 | RYTHMOL | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1989-11-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019151-002 | RYTHMOL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1989-11-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019151-003 | RYTHMOL | 225MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1992-11-20 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019151-001 | RYTHMOL | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1989-11-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019151-002 | RYTHMOL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1989-11-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019151-003 | RYTHMOL | 225MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1992-11-20 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019151-001 | RYTHMOL | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1989-11-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019151-002 | RYTHMOL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1989-11-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019151-003 | RYTHMOL | 225MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1992-11-20 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019151-001 | RYTHMOL | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1989-11-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019151-002 | RYTHMOL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1989-11-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019151-003 | RYTHMOL | 225MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1992-11-20 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019151-001 | RYTHMOL | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1989-11-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019151-002 | RYTHMOL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1989-11-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019151-003 | RYTHMOL | 225MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1992-11-20 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019151-001 | RYTHMOL | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1989-11-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019151-002 | RYTHMOL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1989-11-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019151-003 | RYTHMOL | 225MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1992-11-20 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N019151-001 | RYTHMOL | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1989-11-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N019151-002 | RYTHMOL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1989-11-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N019151-003 | RYTHMOL | 225MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1992-11-20 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019151-001 | RYTHMOL | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1989-11-27 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019151-002 | RYTHMOL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1989-11-27 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019151-003 | RYTHMOL | 225MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1992-11-20 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019151-001 | RYTHMOL | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1989-11-27 | 301d65b070ca… |
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 |
|---|---|---|---|---|---|---|
| Propafenone Hydrochloride | PROPAFENONE HYDROCHLORIDE | Bryant Ranch Prepack | 7bcc5d3b-b2c9-4753-9eef-b5360538f5ee | 2024-08-19 | Boxed warning, Warnings, Adverse reactions | PROPAFENONE HYDROCHLORIDE |
| Propafenone Hydrochloride | PROPAFENONE HYDROCHLORIDE | Zydus Pharmaceuticals (USA) Inc. | 163564b6-a8bf-4258-8ef9-19e33fb2d7bc | 2024-03-23 | Boxed warning, Warnings, Adverse reactions | PROPAFENONE HYDROCHLORIDE |
| Propafenone Hydrochloride | PROPAFENONE HYDROCHLORIDE | Zydus Lifesciences Limited | b41ec863-5734-41a3-9837-6c0a962ec6eb | 2023-12-11 | Boxed warning, Warnings, Adverse reactions | PROPAFENONE HYDROCHLORIDE |
| Propafenone Hydrochloride | PROPAFENONE HYDROCHLORIDE | Bryant Ranch Prepack | 2492317c-8b04-477e-a5d2-53e791fface9 | 2023-11-13 | Boxed warning, Warnings, Adverse reactions | PROPAFENONE HYDROCHLORIDE |
| PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | Aurobindo Pharma Limited | 0c887381-42fe-4f37-858a-d9ffb218dd1c | 2023-07-21 | Boxed warning, Warnings, Adverse reactions | PROPAFENONE HYDROCHLORIDE |
| PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | Rising Pharma Holdings, Inc. | 36cf4555-6fe9-42d8-8d3b-3ca9c134a5b8 | 2020-09-30 | Boxed warning, Warnings, Adverse reactions | PROPAFENONE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.