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| RYTHMOL | PROPAFENONE HYDROCHLORIDE | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1989-11-27 | |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| RYTHMOL | PROPAFENONE HYDROCHLORIDE | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1989-11-27 | |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| RYTHMOL | PROPAFENONE HYDROCHLORIDE | 225MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1992-11-20 |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| 2026-08 | N019151-001 | RYTHMOL | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1989-11-27 | 84e616aacf4f… | |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| 2026-08 | N019151-002 | RYTHMOL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1989-11-27 | 84e616aacf4f… | |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| 2026-08 | N019151-003 | RYTHMOL | 225MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1992-11-20 | 84e616aacf4f… | |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 | Northstar Rx LLC | 2ecd6452-ccc3-493f-9a4a-69f0fbf67a42 | 2026-06-04 | Boxed warning, Warnings, Adverse reactions | PROPAFENONE HYDROCHLORIDE |
| PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | Bryant Ranch Prepack | c8ad1f0f-0e95-4868-a2af-e193c1833841 | 2026-04-20 | Boxed warning, Warnings, Adverse reactions | PROPAFENONE HYDROCHLORIDE |
| PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | Bryant Ranch Prepack | faa8e971-4b4f-43db-be97-33acc16dcdc7 | 2026-04-20 | Boxed warning, Warnings, Adverse reactions | PROPAFENONE HYDROCHLORIDE |
| PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | Bryant Ranch Prepack | 80f174e1-f249-4f34-806d-20e643084429 | 2026-04-20 | Boxed warning, Warnings, Adverse reactions | PROPAFENONE HYDROCHLORIDE |
| Propafenone Hydrochloride | PROPAFENONE HYDROCHLORIDE | A-S Medication Solutions | 41b4e503-60a6-4662-a6f9-46ecf93d930a | 2026-03-27 | Boxed warning, Warnings, Adverse reactions | PROPAFENONE HYDROCHLORIDE |
| Propafenone Hydrochloride | PROPAFENONE HYDROCHLORIDE | Bryant Ranch Prepack | 680a803d-3d4d-4ca3-b1ce-7d7e3ff8a626 | 2026-02-26 | Boxed warning, Warnings, Adverse reactions | PROPAFENONE HYDROCHLORIDE |
| Propafenone Hydrochloride | PROPAFENONE HYDROCHLORIDE | Bryant Ranch Prepack | 5c8cebcd-699f-4c4c-900b-94e0fe519345 | 2026-02-26 | Boxed warning, Warnings, Adverse reactions | PROPAFENONE HYDROCHLORIDE |
| Propafenone Hydrochloride | PROPAFENONE HYDROCHLORIDE | Bryant Ranch Prepack | 739b7624-952d-4343-b720-974d30e284d9 | 2026-02-26 | Boxed warning, Warnings, Adverse reactions | PROPAFENONE HYDROCHLORIDE |
| propafenone hydrochloride | PROPAFENONE HYDROCHLORIDE | Glenmark Pharmaceuticals Inc., USA | d818af31-2535-4595-82fe-fd7abf66fd6c | 2026-01-29 | Boxed warning, Warnings, Adverse reactions | PROPAFENONE HYDROCHLORIDE |
| Propafenone Hydrochloride | PROPAFENONE HYDROCHLORIDE | Upsher-Smith Laboratories, LLC | 8aa6f58a-2980-4caa-9c54-d55d69d5d132 | 2025-12-11 | Boxed warning, Warnings, Adverse reactions | PROPAFENONE HYDROCHLORIDE |
| Propafenone Hydrochloride | PROPAFENONE HYDROCHLORIDE | Golden State Medical Supply, Inc. | 7202aed6-40a9-2bff-e053-2a95a90ae752 | 2025-11-19 | Boxed warning, Warnings, Adverse reactions | PROPAFENONE HYDROCHLORIDE |
| Propafenone Hydrochloride | PROPAFENONE HYDROCHLORIDE | Bryant Ranch Prepack | a6ac2a70-e0ec-4fcd-8732-5f1637be1e60 | 2025-11-17 | Boxed warning, Warnings, Adverse reactions | PROPAFENONE HYDROCHLORIDE |
| PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | American Health Packaging | da08c286-b930-463a-858a-efc54f12019f | 2025-10-21 | Boxed warning, Warnings, Adverse reactions | PROPAFENONE HYDROCHLORIDE |
| Propafenone Hydrochloride | PROPAFENONE HYDROCHLORIDE | Bryant Ranch Prepack | 617faff7-d9e4-477d-ab2c-aded5c129a86 | 2025-10-13 | Boxed warning, Warnings, Adverse reactions | PROPAFENONE HYDROCHLORIDE |
| Propafenone Hydrochloride | PROPAFENONE HYDROCHLORIDE | American Health Packaging | 343e4ad7-05e2-4e6c-8f8e-91c07739cae2 | 2025-09-18 | Boxed warning, Warnings, Adverse reactions | PROPAFENONE HYDROCHLORIDE |
| Propafenone Hydrochloride | PROPAFENONE HYDROCHLORIDE | ANI Pharmaceuticals, Inc. | 8d1be333-be2b-4064-86a4-c2ad9ad07b83 | 2025-09-12 | Boxed warning, Warnings, Adverse reactions | PROPAFENONE HYDROCHLORIDE |
| PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | Strides Pharma Science Limited | c65253ab-937f-4982-b841-69c2b9f9ccdb | 2025-09-01 | Boxed warning, Warnings, Adverse reactions | PROPAFENONE HYDROCHLORIDE |
| PROPAFENONE HYDROCHLORIDE | PROPAFENONE HYDROCHLORIDE | Strides Pharma Science Limited | a96f9c6f-4c9c-4406-bca8-08bf9a4af1f4 | 2025-03-27 | Boxed warning, Warnings, Adverse reactions | PROPAFENONE HYDROCHLORIDE |
| Propafenone Hydrochloride | PROPAFENONE HYDROCHLORIDE | Aurobindo Pharma Limited | 1c4fc726-3f5b-4b12-a66e-727c5133d1d9 | 2025-02-04 | Boxed warning, Warnings, Adverse reactions | PROPAFENONE HYDROCHLORIDE |
| Propafenone Hydrochloride | PROPAFENONE HYDROCHLORIDE | Bryant Ranch Prepack | 9da7e6d2-64da-43cd-9575-b2b0d5d412dc | 2024-10-03 | Boxed warning, Warnings, Adverse reactions | PROPAFENONE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.