Application 201743
- Type
- NDA
- Sponsor
- SANDOZ
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ARGATROBAN IN DEXTROSE | ARGATROBAN | SOLUTION;INTRAVENOUS | 125MG/125ML (1MG/ML) | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N201743-001 | ARGATROBAN IN DEXTROSE | ARGATROBAN | 125MG/125ML (1MG/ML) | SOLUTION / INTRAVENOUS | 2011-05-09 |
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 | N201743-001 | ARGATROBAN IN DEXTROSE | 125MG/125ML (1MG/ML) | SOLUTION / INTRAVENOUS | 2011-05-09 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N201743-001 | ARGATROBAN IN DEXTROSE | 125MG/125ML (1MG/ML) | SOLUTION / INTRAVENOUS | 2011-05-09 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N201743-001 | ARGATROBAN IN DEXTROSE | 125MG/125ML (1MG/ML) | SOLUTION / INTRAVENOUS | 2011-05-09 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N201743-001 | ARGATROBAN IN DEXTROSE | 125MG/125ML (1MG/ML) | SOLUTION / INTRAVENOUS | 2011-05-09 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N201743-001 | ARGATROBAN IN DEXTROSE | 125MG/125ML (1MG/ML) | SOLUTION / INTRAVENOUS | 2011-05-09 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N201743-001 | ARGATROBAN IN DEXTROSE | 125MG/125ML (1MG/ML) | SOLUTION / INTRAVENOUS | 2011-05-09 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N201743-001 | ARGATROBAN IN DEXTROSE | 125MG/125ML (1MG/ML) | SOLUTION / INTRAVENOUS | 2011-05-09 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N201743-001 | ARGATROBAN IN DEXTROSE | 125MG/125ML (1MG/ML) | SOLUTION / INTRAVENOUS | 2011-05-09 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N201743-001 | ARGATROBAN IN DEXTROSE | 125MG/125ML (1MG/ML) | SOLUTION / INTRAVENOUS | 2011-05-09 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N201743-001 | ARGATROBAN IN DEXTROSE | 125MG/125ML (1MG/ML) | SOLUTION / INTRAVENOUS | 2011-05-09 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N201743-001 | ARGATROBAN IN DEXTROSE | 125MG/125ML (1MG/ML) | SOLUTION / INTRAVENOUS | 2011-05-09 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N201743-001 | ARGATROBAN IN DEXTROSE | 125MG/125ML (1MG/ML) | SOLUTION / INTRAVENOUS | 2011-05-09 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N201743-001 | ARGATROBAN IN DEXTROSE | 125MG/125ML (1MG/ML) | SOLUTION / INTRAVENOUS | 2011-05-09 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N201743-001 | ARGATROBAN IN DEXTROSE | 125MG/125ML (1MG/ML) | SOLUTION / INTRAVENOUS | 2011-05-09 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N201743-001 | ARGATROBAN IN DEXTROSE | 125MG/125ML (1MG/ML) | SOLUTION / INTRAVENOUS | 2011-05-09 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N201743-001 | ARGATROBAN IN DEXTROSE | 125MG/125ML (1MG/ML) | SOLUTION / INTRAVENOUS | 2011-05-09 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N201743-001 | ARGATROBAN IN DEXTROSE | 125MG/125ML (1MG/ML) | SOLUTION / INTRAVENOUS | 2011-05-09 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N201743-001 | ARGATROBAN IN DEXTROSE | 125MG/125ML (1MG/ML) | SOLUTION / INTRAVENOUS | 2011-05-09 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N201743-001 | ARGATROBAN IN DEXTROSE | 125MG/125ML (1MG/ML) | SOLUTION / INTRAVENOUS | 2011-05-09 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N201743-001 | ARGATROBAN IN DEXTROSE | 125MG/125ML (1MG/ML) | SOLUTION / INTRAVENOUS | 2011-05-09 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N201743-001 | ARGATROBAN IN DEXTROSE | 125MG/125ML (1MG/ML) | SOLUTION / INTRAVENOUS | 2011-05-09 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N201743-001 | ARGATROBAN IN DEXTROSE | 125MG/125ML (1MG/ML) | SOLUTION / INTRAVENOUS | 2011-05-09 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N201743-001 | ARGATROBAN IN DEXTROSE | 125MG/125ML (1MG/ML) | SOLUTION / INTRAVENOUS | 2011-05-09 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N201743-001 | ARGATROBAN IN DEXTROSE | 125MG/125ML (1MG/ML) | SOLUTION / INTRAVENOUS | 2011-05-09 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N201743-001 | ARGATROBAN IN DEXTROSE | 125MG/125ML (1MG/ML) | SOLUTION / INTRAVENOUS | 2011-05-09 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N201743-001 | ARGATROBAN IN DEXTROSE | 125MG/125ML (1MG/ML) | SOLUTION / INTRAVENOUS | 2011-05-09 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N201743-001 | ARGATROBAN IN DEXTROSE | 125MG/125ML (1MG/ML) | SOLUTION / INTRAVENOUS | 2011-05-09 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N201743-001 | ARGATROBAN IN DEXTROSE | 125MG/125ML (1MG/ML) | SOLUTION / INTRAVENOUS | 2011-05-09 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N201743-001 | ARGATROBAN IN DEXTROSE | 125MG/125ML (1MG/ML) | SOLUTION / INTRAVENOUS | 2011-05-09 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N201743-001 | ARGATROBAN IN DEXTROSE | 125MG/125ML (1MG/ML) | SOLUTION / INTRAVENOUS | 2011-05-09 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N201743-001 | ARGATROBAN IN DEXTROSE | 125MG/125ML (1MG/ML) | SOLUTION / INTRAVENOUS | 2011-05-09 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N201743-001 | ARGATROBAN IN DEXTROSE | 125MG/125ML (1MG/ML) | SOLUTION / INTRAVENOUS | 2011-05-09 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N201743-001 | ARGATROBAN IN DEXTROSE | 125MG/125ML (1MG/ML) | SOLUTION / INTRAVENOUS | 2011-05-09 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N201743-001 | ARGATROBAN IN DEXTROSE | 125MG/125ML (1MG/ML) | SOLUTION / INTRAVENOUS | 2011-05-09 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N201743-001 | ARGATROBAN IN DEXTROSE | 125MG/125ML (1MG/ML) | SOLUTION / INTRAVENOUS | 2011-05-09 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N201743-001 | ARGATROBAN IN DEXTROSE | 125MG/125ML (1MG/ML) | SOLUTION / INTRAVENOUS | 2011-05-09 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N201743-001 | ARGATROBAN IN DEXTROSE | 125MG/125ML (1MG/ML) | SOLUTION / INTRAVENOUS | 2011-05-09 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N201743-001 | ARGATROBAN IN DEXTROSE | 125MG/125ML (1MG/ML) | SOLUTION / INTRAVENOUS | 2011-05-09 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N201743-001 | ARGATROBAN IN DEXTROSE | 125MG/125ML (1MG/ML) | SOLUTION / INTRAVENOUS | 2011-05-09 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N201743-001 | ARGATROBAN IN DEXTROSE | 125MG/125ML (1MG/ML) | SOLUTION / INTRAVENOUS | 2011-05-09 | 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 |
|---|---|---|---|---|---|---|
| Argatroban | ARGATROBAN | Par Health USA, LLC | 1a67a87d-59cb-414c-a11e-ab8f0a9bb778 | 2026-08-20 | Warnings, Adverse reactions | ARGATROBAN |
| Argatroban | ARGATROBAN | Par Health USA, LLC | d4e5238f-2378-424e-bda2-f1a2cf874041 | 2026-08-19 | Warnings, Adverse reactions | ARGATROBAN |
| Argatroban | ARGATROBAN | Sagent Pharmaceuticals | 629aee90-3bf3-4947-a978-21cbba2e1c41 | 2026-07-29 | Warnings, Adverse reactions | ARGATROBAN |
| Argatroban | ARGATROBAN | Mullan Pharmaceutical Inc. | 546484ed-afab-b47b-e063-6394a90aa52d | 2026-06-16 | Warnings, Adverse reactions | ARGATROBAN |
| Argatroban | ARGATROBAN | Mullan Pharmaceutical Inc. | 50e21062-f021-40f2-ad11-896f46378a15 | 2026-06-15 | Warnings, Adverse reactions | ARGATROBAN |
| Argatroban | ARGATROBAN | Gland Pharma Limited | 270dbb59-e080-4a64-91d9-a68bed4bd2e5 | 2026-06-09 | Warnings, Adverse reactions | ARGATROBAN |
| ARGATROBAN | ARGATROBAN | Accord Healthcare Inc. | 46cdf9e6-839c-49c8-9ee1-c30cfdd9368d | 2026-05-21 | Warnings, Adverse reactions | ARGATROBAN |
| Argatroban | ARGATROBAN | Hikma Pharmaceuticals USA Inc. | 0cdf3f67-5bf3-4d58-b330-03febdc652bf | 2026-05-03 | Warnings, Adverse reactions | ARGATROBAN |
| ARGATROBAN | ARGATROBAN | Caplin Steriles Limited | b5143563-ff45-433a-a9e2-f8b8340db1f5 | 2026-04-17 | Warnings, Adverse reactions | ARGATROBAN |
| Argatroban | ARGATROBAN | Gland Pharma Limited | e5ccb93c-f411-4e7e-824a-4a592b4947ec | 2026-03-17 | Warnings, Adverse reactions | ARGATROBAN |
| Argatroban | ARGATROBAN | Fresenius Kabi USA, LLC | dfa5d325-f609-4c9a-aaae-1a17df47da1e | 2025-09-03 | Warnings, Adverse reactions | ARGATROBAN |
| Argatroban | ARGATROBAN | Mylan Institutional LLC | b0dedf95-8395-46bf-b94a-dcf2dd085942 | 2025-08-15 | Warnings, Adverse reactions | ARGATROBAN |
| Argatroban | ARGATROBAN | Hikma Pharmaceuticals USA Inc. | 41f56fe7-4824-4032-aa73-cfb4f8db2252 | 2024-04-11 | Warnings, Adverse reactions | ARGATROBAN |
| Argatroban | ARGATROBAN | Hikma Pharmaceuticals USA Inc. | 79eec27d-ac63-4996-8b1a-c2cd52ad2b2c | 2024-04-11 | Warnings, Adverse reactions | ARGATROBAN |
| Argatroban | ARGATROBAN | Eugia US LLC | d9b975bd-e3f4-466e-96ca-7bef7899506d | 2023-08-03 | Warnings, Adverse reactions | ARGATROBAN |
| Argatroban | ARGATROBAN | Amneal Pharmaceuticals LLC | dedef330-555a-46b7-b1d6-0838b4cd9651 | 2019-05-23 | Warnings, Adverse reactions | ARGATROBAN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.