Application 018830
- Type
- NDA
- Sponsor
- CNTY LINE PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TAMBOCOR | FLECAINIDE ACETATE | TABLET;ORAL | 100MG | Yes | No |
| 002 | TAMBOCOR | FLECAINIDE ACETATE | TABLET;ORAL | 200MG | No | No |
| 003 | TAMBOCOR | FLECAINIDE ACETATE | TABLET;ORAL | 150MG | Yes | No |
| 004 | TAMBOCOR | FLECAINIDE ACETATE | TABLET;ORAL | 50MG | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N018830-001 | TAMBOCOR | FLECAINIDE ACETATE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1985-10-31 | |
| N018830-002 | TAMBOCOR | FLECAINIDE ACETATE | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1985-10-31 | ||
| N018830-003 | TAMBOCOR | FLECAINIDE ACETATE | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-06-03 | |
| N018830-004 | TAMBOCOR | FLECAINIDE ACETATE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-08-23 |
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| 2026-08 | N018830-001 | TAMBOCOR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1985-10-31 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N018830-002 | TAMBOCOR | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1985-10-31 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N018830-003 | TAMBOCOR | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-06-03 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N018830-004 | TAMBOCOR | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-08-23 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N018830-001 | TAMBOCOR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1985-10-31 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N018830-002 | TAMBOCOR | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1985-10-31 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N018830-003 | TAMBOCOR | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-06-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N018830-004 | TAMBOCOR | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-08-23 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018830-001 | TAMBOCOR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1985-10-31 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018830-002 | TAMBOCOR | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1985-10-31 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N018830-003 | TAMBOCOR | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-06-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018830-004 | TAMBOCOR | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-08-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018830-001 | TAMBOCOR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1985-10-31 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018830-002 | TAMBOCOR | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1985-10-31 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018830-003 | TAMBOCOR | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-06-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018830-004 | TAMBOCOR | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-08-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018830-001 | TAMBOCOR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1985-10-31 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018830-002 | TAMBOCOR | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1985-10-31 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N018830-003 | TAMBOCOR | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-06-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018830-004 | TAMBOCOR | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-08-23 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018830-001 | TAMBOCOR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1985-10-31 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018830-002 | TAMBOCOR | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1985-10-31 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018830-003 | TAMBOCOR | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-06-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018830-004 | TAMBOCOR | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-08-23 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018830-001 | TAMBOCOR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1985-10-31 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018830-002 | TAMBOCOR | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1985-10-31 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018830-003 | TAMBOCOR | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-06-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018830-004 | TAMBOCOR | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-08-23 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018830-001 | TAMBOCOR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1985-10-31 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018830-002 | TAMBOCOR | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1985-10-31 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018830-003 | TAMBOCOR | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-06-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018830-004 | TAMBOCOR | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-08-23 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018830-001 | TAMBOCOR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1985-10-31 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018830-002 | TAMBOCOR | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1985-10-31 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018830-003 | TAMBOCOR | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-06-03 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018830-004 | TAMBOCOR | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-08-23 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018830-001 | TAMBOCOR | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1985-10-31 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018830-002 | TAMBOCOR | 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | 1985-10-31 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018830-003 | TAMBOCOR | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-06-03 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018830-004 | TAMBOCOR | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-08-23 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N018830-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N018830-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N018830-004 | AB | 1 | 74a2ff9319b5… |
| 2020-12-22 03:56 UTC | 2020-12 | N018830-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N018830-003 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N018830-004 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N018830-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N018830-003 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N018830-004 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N018830-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N018830-003 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N018830-004 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N018830-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N018830-003 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N018830-004 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N018830-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N018830-003 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N018830-004 | AB | 1 | ea99ee380514… |
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 |
|---|---|---|---|---|---|---|
| Flecainide Acetate | FLECAINIDE ACETATE | Bryant Ranch Prepack | 2013e6ef-9141-42c3-8ea8-285840ecdd15 | 2024-04-03 | Boxed warning, Adverse reactions | FLECAINIDE ACETATE |
| Flecainide Acetate | FLECAINIDE ACETATE | Bryant Ranch Prepack | 5d6a4772-663e-468d-a8e1-4085e1b32bf7 | 2024-04-03 | Boxed warning, Adverse reactions | FLECAINIDE ACETATE |
| Flecainide Acetate | FLECAINIDE ACETATE | Aurobindo Pharma Limited | 14e89448-3a18-42e3-8537-2589be1ef94e | 2024-01-09 | Boxed warning, Adverse reactions | FLECAINIDE ACETATE |
| Flecainide Acetate | FLECAINIDE ACETATE | Rising Pharma Holdings, Inc. | e56335c1-5508-4136-bd2e-18385623e497 | 2024-01-09 | Boxed warning, Adverse reactions | FLECAINIDE ACETATE |
| Flecainide Acetate | FLECAINIDE ACETATE | A-S Medication Solutions | 179e3821-0342-4b84-96bb-3fcab213d74f | 2023-11-30 | Boxed warning, Warnings, Adverse reactions | FLECAINIDE ACETATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 43199-056 | Flecainide acetate | Flecainide acetate | County Line Pharmaceuticals, LLC | NDA | Current |
| 43199-057 | Flecainide acetate | Flecainide acetate | County Line Pharmaceuticals, LLC | NDA | Current |
| 43199-058 | Flecainide acetate | Flecainide acetate | County Line Pharmaceuticals, LLC | NDA | Current |