Application 020377
- Type
- NDA
- Sponsor
- WYETH PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CORDARONE | AMIODARONE HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| N020377-001 | CORDARONE | AMIODARONE HYDROCHLORIDE | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-08-03 |
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| 2026-08 | N020377-001 | CORDARONE | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-08-03 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N020377-001 | CORDARONE | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-08-03 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020377-001 | CORDARONE | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-08-03 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020377-001 | CORDARONE | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-08-03 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020377-001 | CORDARONE | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-08-03 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020377-001 | CORDARONE | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-08-03 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020377-001 | CORDARONE | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-08-03 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020377-001 | CORDARONE | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-08-03 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020377-001 | CORDARONE | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-08-03 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020377-001 | CORDARONE | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-08-03 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020377-001 | CORDARONE | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-08-03 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020377-001 | CORDARONE | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-08-03 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020377-001 | CORDARONE | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-08-03 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020377-001 | CORDARONE | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-08-03 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020377-001 | CORDARONE | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-08-03 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N020377-001 | CORDARONE | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-08-03 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020377-001 | CORDARONE | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-08-03 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N020377-001 | CORDARONE | 50MG/ML | INJECTABLE / INJECTION | RLD | 1995-08-03 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N020377-001 | CORDARONE | 50MG/ML | INJECTABLE / INJECTION | RLD | 1995-08-03 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020377-001 | CORDARONE | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1995-08-03 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N020377-001 | CORDARONE | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-08-03 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N020377-001 | CORDARONE | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1995-08-03 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020377-001 | CORDARONE | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1995-08-03 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N020377-001 | CORDARONE | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1995-08-03 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N020377-001 | CORDARONE | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1995-08-03 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N020377-001 | CORDARONE | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1995-08-03 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N020377-001 | CORDARONE | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1995-08-03 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N020377-001 | CORDARONE | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1995-08-03 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N020377-001 | CORDARONE | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1995-08-03 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N020377-001 | CORDARONE | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-08-03 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N020377-001 | CORDARONE | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-08-03 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N020377-001 | CORDARONE | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-08-03 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N020377-001 | CORDARONE | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-08-03 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N020377-001 | CORDARONE | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-08-03 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N020377-001 | CORDARONE | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-08-03 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N020377-001 | CORDARONE | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-08-03 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N020377-001 | CORDARONE | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-08-03 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N020377-001 | CORDARONE | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-08-03 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N020377-001 | CORDARONE | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-08-03 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N020377-001 | CORDARONE | 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1995-08-03 | f41ea6bd6efb… |
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 |
|---|---|---|---|---|---|---|
| Amiodarone Hydrochloride | AMIODARONE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 81a15062-ba1e-37c0-e053-2991aa0af945 | 2023-05-16 | Warnings, Adverse reactions | AMIODARONE HYDROCHLORIDE |
| Amiodarone Hydrochloride | AMIODARONE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 8969aad3-0219-e67f-e053-2995a90aac5a | 2023-05-15 | Warnings, Adverse reactions | AMIODARONE HYDROCHLORIDE |
| Amiodarone Hydrochloride | AMIODARONE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | 66700f8b-3f76-3749-e053-2a91aa0adfdb | 2023-04-18 | Warnings, Adverse reactions | AMIODARONE HYDROCHLORIDE |
| amiodarone hydrochloride | AMIODARONE HYDROCHLORIDE | Zydus Pharmaceuticals USA Inc. | b41cbcb5-9c5d-4e45-a4f2-952df5f22c00 | 2023-03-16 | Boxed warning, Warnings, Adverse reactions | AMIODARONE HYDROCHLORIDE |
| Amiodarone Hydrochloride | AMIODARONE HYDROCHLORIDE | Unichem Pharmaceuticals (USA), Inc. | a20d0c03-cfda-49d1-88c9-be1bf295bc6c | 2023-02-23 | Boxed warning, Warnings, Adverse reactions | AMIODARONE HYDROCHLORIDE |
| Amiodarone Hydrochloride | AMIODARONE HYDROCHLORIDE | Mylan Institutional LLC | f0b3b743-9f62-4b02-ace5-c8d93637ecad | 2022-03-15 | Warnings, Adverse reactions | AMIODARONE HYDROCHLORIDE |
| Amiodarone Hydrochloride | AMIODARONE HYDROCHLORIDE | AuroMedics Pharma LLC | 6cd870d7-6381-421a-89bc-bce5c9518219 | 2021-12-08 | Warnings, Adverse reactions | AMIODARONE HYDROCHLORIDE |
| Amiodarone hydrochloride | AMIODARONE HYDROCHLORIDE | Gland Pharma Limited | 1f00c333-9667-4ebc-8849-009a3779c0c9 | 2021-08-26 | Warnings, Adverse reactions | AMIODARONE HYDROCHLORIDE |
| Amiodarone Hydrochloride | AMIODARONE HYDROCHLORIDE | Mylan Institutional LLC | fcc8658c-761a-443f-8c32-1499d86028ec | 2020-07-15 | Warnings, Adverse reactions | AMIODARONE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 2421 | SUPPL | 2006-09-18 |
| 2420 | SUPPL | 2005-09-22 |
| 23579 | ORIG | 2005-07-29 |
| 24863 | SUPPL | 2004-11-08 |
| 2419 | SUPPL | 2004-11-08 |
| 2418 | SUPPL | 2004-11-08 |
| 2416 | SUPPL | 2004-11-08 |
| 24867 | SUPPL | 2004-09-03 |
| 41313 | SUPPL | 2003-08-08 |
| 20618 | SUPPL | 2003-08-08 |
| 24866 | SUPPL | 2003-05-30 |
| 24865 | SUPPL | 2003-05-30 |
| 24864 | SUPPL | 2003-05-30 |
| 2417 | SUPPL | 2003-05-30 |
| 24862 | SUPPL | 2001-07-11 |
| 2415 | SUPPL | 2001-07-11 |