Application 076394
- Type
- ANDA
- Sponsor
- PAR STERILE PRODUCTS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076394-001 | AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | 2003-04-25 |
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 | A076394-001 | AMIODARONE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | 2003-04-25 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A076394-001 | AMIODARONE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | 2003-04-25 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A076394-001 | AMIODARONE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | 2003-04-25 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076394-001 | AMIODARONE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | 2003-04-25 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076394-001 | AMIODARONE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | 2003-04-25 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076394-001 | AMIODARONE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | 2003-04-25 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076394-001 | AMIODARONE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | 2003-04-25 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076394-001 | AMIODARONE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | 2003-04-25 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076394-001 | AMIODARONE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | 2003-04-25 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076394-001 | AMIODARONE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | 2003-04-25 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076394-001 | AMIODARONE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | 2003-04-25 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076394-001 | AMIODARONE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | 2003-04-25 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076394-001 | AMIODARONE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | 2003-04-25 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076394-001 | AMIODARONE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | 2003-04-25 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076394-001 | AMIODARONE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | 2003-04-25 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076394-001 | AMIODARONE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | 2003-04-25 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076394-001 | AMIODARONE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | 2003-04-25 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076394-001 | AMIODARONE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | 2003-04-25 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076394-001 | AMIODARONE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | 2003-04-25 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076394-001 | AMIODARONE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | 2003-04-25 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076394-001 | AMIODARONE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | 2003-04-25 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A076394-001 | AMIODARONE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | 2003-04-25 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076394-001 | AMIODARONE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | 2003-04-25 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A076394-001 | AMIODARONE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | 2003-04-25 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A076394-001 | AMIODARONE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | 2003-04-25 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A076394-001 | AMIODARONE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | 2003-04-25 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A076394-001 | AMIODARONE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | 2003-04-25 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A076394-001 | AMIODARONE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | 2003-04-25 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A076394-001 | AMIODARONE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | 2003-04-25 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A076394-001 | AMIODARONE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | 2003-04-25 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A076394-001 | AMIODARONE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | 2003-04-25 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A076394-001 | AMIODARONE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | 2003-04-25 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076394-001 | AMIODARONE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | 2003-04-25 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076394-001 | AMIODARONE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | 2003-04-25 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076394-001 | AMIODARONE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | 2003-04-25 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076394-001 | AMIODARONE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | 2003-04-25 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A076394-001 | AMIODARONE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | 2003-04-25 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A076394-001 | AMIODARONE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | 2003-04-25 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A076394-001 | AMIODARONE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | 2003-04-25 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A076394-001 | AMIODARONE HYDROCHLORIDE | 50MG/ML | INJECTABLE / INJECTION | 2003-04-25 | 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 | Advagen Pharma Limited | d911b4cf-eec4-43f8-aa64-cc60cfc901b9 | 2025-12-09 | Boxed warning, Warnings, Adverse reactions | Amiodarone Hydrochloride AMIODARONE HYDROCHLORIDE |
| Amiodarone Hydrochloride | AMIODARONE HYDROCHLORIDE | Chartwell RX, LLC | 5520f11d-968d-4f4f-bf57-d14369c0d746 | 2025-12-09 | Boxed warning, Warnings, Adverse reactions | Amiodarone Hydrochloride AMIODARONE HYDROCHLORIDE |
| Amiodarone Hydrochloride | AMIODARONE HYDROCHLORIDE | American Health Packaging | d912a75a-ddac-4e7b-b5c4-321d4252ec05 | 2025-11-13 | Boxed warning, Warnings, Adverse reactions | Amiodarone Hydrochloride AMIODARONE HYDROCHLORIDE |
| Pacerone | AMIODARONE HYDROCHLORIDE | Bryant Ranch Prepack | dcadce9c-d0a0-4235-8ff8-dd93c09e03b3 | 2025-11-05 | Boxed warning, Warnings, Adverse reactions | AMIODARONE HYDROCHLORIDE |
| AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | Henry Schein, Inc. | 0c9ee15a-5741-4aaa-8d80-c7bd2e45822e | 2025-10-29 | Warnings, Adverse reactions | AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE |
| Amiodarone Hydrochloride | AMIODARONE HYDROCHLORIDE | Medical Purchasing Solutions, LLC. | 4240b2e9-be05-3de5-e063-6394a90a4bb2 | 2025-10-28 | Warnings, Adverse reactions | Amiodarone Hydrochloride AMIODARONE HYDROCHLORIDE |
| Pacerone | AMIODARONE HYDROCHLORIDE | Upsher-Smith Laboratories, LLC | 4c4ec9b0-13a5-49a8-b57b-b3f64e4316a7 | 2025-07-14 | Boxed warning, Warnings, Adverse reactions | AMIODARONE HYDROCHLORIDE |
| Amiodarone Hydrochloride | AMIODARONE HYDROCHLORIDE | Slate Run Pharmaceuticals | 3a53668c-adda-44c2-a743-e79e467437e3 | 2025-04-01 | Warnings, Adverse reactions | Amiodarone Hydrochloride AMIODARONE HYDROCHLORIDE |
| Amiodarone Hydrochloride | AMIODARONE HYDROCHLORIDE | Fresenius Kabi USA, LLC | d8d04647-8e25-4127-8ecf-360ce1991c2f | 2025-03-31 | Warnings, Adverse reactions | Amiodarone Hydrochloride AMIODARONE HYDROCHLORIDE |
| Amiodarone Hydrochloride | AMIODARONE HYDROCHLORIDE | Fresenius Kabi USA, LLC | 9772ab48-2ef1-4b9f-9a27-794f3e7e5c7a | 2025-03-06 | Warnings, Adverse reactions | Amiodarone Hydrochloride AMIODARONE HYDROCHLORIDE |
| Amiodarone hydrochloride | AMIODARONE HYDROCHLORIDE | Zydus Lifesciences Limited | 3e8db251-e3c5-4fba-be9a-6044a92f0beb | 2024-11-25 | Amiodarone hydrochloride AMIODARONE HYDROCHLORIDE | |
| Amiodarone Hydrochloride | AMIODARONE HYDROCHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | d42293e9-07fa-41b4-a08b-2e388f5b1e13 | 2024-08-09 | Boxed warning, Warnings, Adverse reactions | Amiodarone Hydrochloride AMIODARONE HYDROCHLORIDE |
| Nexterone | AMIODARONE HYDROCHLORIDE | Baxter Healthcare Corporation | e9108958-b8d7-4fba-87c3-9a32990de551 | 2024-04-16 | Warnings, Adverse reactions | AMIODARONE HYDROCHLORIDE |
| Amiodarone Hydrochloride | AMIODARONE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 51772745-9ea9-42cd-97e6-7266f41ae3ca | 2024-04-11 | Warnings, Adverse reactions | Amiodarone Hydrochloride AMIODARONE HYDROCHLORIDE |
| AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | 7639dfe4-933c-2916-e053-2a91aa0a3fe7 | 2024-02-22 | Warnings, Adverse reactions | AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE |
| Pacerone | AMIODARONE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 02f4a736-63ed-4ad4-a1f1-b21a71e928bd | 2024-02-02 | Boxed warning, Warnings, Adverse reactions | AMIODARONE HYDROCHLORIDE |
| AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | 8d088060-70b5-e796-e053-2995a90a0969 | 2024-01-28 | Warnings, Adverse reactions | AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE |
| Amiodarone Hydrochloride | AMIODARONE HYDROCHLORIDE | A-S Medication Solutions | bfd14110-4bf8-4fbe-a888-7b23fea6ffaa | 2024-01-26 | Boxed warning, Warnings, Adverse reactions | Amiodarone Hydrochloride AMIODARONE HYDROCHLORIDE |
| Amiodarone Hydrochloride | AMIODARONE HYDROCHLORIDE | A-S Medication Solutions | c536e0ad-2758-4022-8242-f5e9b6aca1e2 | 2023-08-22 | Boxed warning, Warnings, Adverse reactions | Amiodarone Hydrochloride AMIODARONE HYDROCHLORIDE |
| Amiodarone Hydrochloride | AMIODARONE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | d889c00c-e27e-4e27-e053-2995a90ad4e1 | 2023-06-01 | Warnings, Adverse reactions | Amiodarone Hydrochloride AMIODARONE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.