Application 206812
- Type
- ANDA
- Sponsor
- JIANGSU HENGRUI MED
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | INJECTABLE;SUBCUTANEOUS | 2.5MG/0.5ML | No | No |
| 002 | FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | INJECTABLE;SUBCUTANEOUS | 5MG/0.4ML | No | No |
| 003 | FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | INJECTABLE;SUBCUTANEOUS | 7.5MG/0.6ML | No | No |
| 004 | FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | INJECTABLE;SUBCUTANEOUS | 10MG/0.8ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A206812-001 | FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | 2.5MG/0.5ML (2.5MG/0.5ML) | SOLUTION / SUBCUTANEOUS | 2018-05-15 | ||
| A206812-002 | FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | 5MG/0.4ML (5MG/0.4ML) | SOLUTION / SUBCUTANEOUS | 2018-05-15 | ||
| A206812-003 | FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | 7.5MG/0.6ML (7.5MG/0.6ML) | SOLUTION / SUBCUTANEOUS | 2018-05-15 | ||
| A206812-004 | FONDAPARINUX SODIUM | FONDAPARINUX SODIUM | 10MG/0.8ML (10MG/0.8ML) | SOLUTION / SUBCUTANEOUS | 2018-05-15 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A206812-001 | FONDAPARINUX SODIUM | 2.5MG/0.5ML (2.5MG/0.5ML) | SOLUTION / SUBCUTANEOUS | 2018-05-15 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A206812-002 | FONDAPARINUX SODIUM | 5MG/0.4ML (5MG/0.4ML) | SOLUTION / SUBCUTANEOUS | 2018-05-15 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A206812-003 | FONDAPARINUX SODIUM | 7.5MG/0.6ML (7.5MG/0.6ML) | SOLUTION / SUBCUTANEOUS | 2018-05-15 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A206812-004 | FONDAPARINUX SODIUM | 10MG/0.8ML (10MG/0.8ML) | SOLUTION / SUBCUTANEOUS | 2018-05-15 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A206812-001 | FONDAPARINUX SODIUM | 2.5MG/0.5ML | SOLUTION / SUBCUTANEOUS | AP | 2018-05-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206812-002 | FONDAPARINUX SODIUM | 5MG/0.4ML | SOLUTION / SUBCUTANEOUS | AP | 2018-05-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206812-003 | FONDAPARINUX SODIUM | 7.5MG/0.6ML | SOLUTION / SUBCUTANEOUS | AP | 2018-05-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206812-004 | FONDAPARINUX SODIUM | 10MG/0.8ML | SOLUTION / SUBCUTANEOUS | AP | 2018-05-15 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206812-001 | FONDAPARINUX SODIUM | 2.5MG/0.5ML | INJECTABLE / SUBCUTANEOUS | AP | 2018-05-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206812-002 | FONDAPARINUX SODIUM | 5MG/0.4ML | INJECTABLE / SUBCUTANEOUS | AP | 2018-05-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206812-003 | FONDAPARINUX SODIUM | 7.5MG/0.6ML | INJECTABLE / SUBCUTANEOUS | AP | 2018-05-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206812-004 | FONDAPARINUX SODIUM | 10MG/0.8ML | INJECTABLE / SUBCUTANEOUS | AP | 2018-05-15 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206812-001 | FONDAPARINUX SODIUM | 2.5MG/0.5ML | INJECTABLE / SUBCUTANEOUS | AP | 2018-05-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206812-002 | FONDAPARINUX SODIUM | 5MG/0.4ML | INJECTABLE / SUBCUTANEOUS | AP | 2018-05-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206812-003 | FONDAPARINUX SODIUM | 7.5MG/0.6ML | INJECTABLE / SUBCUTANEOUS | AP | 2018-05-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206812-004 | FONDAPARINUX SODIUM | 10MG/0.8ML | INJECTABLE / SUBCUTANEOUS | AP | 2018-05-15 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206812-001 | FONDAPARINUX SODIUM | 2.5MG/0.5ML | INJECTABLE / SUBCUTANEOUS | AP | 2018-05-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206812-002 | FONDAPARINUX SODIUM | 5MG/0.4ML | INJECTABLE / SUBCUTANEOUS | AP | 2018-05-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206812-003 | FONDAPARINUX SODIUM | 7.5MG/0.6ML | INJECTABLE / SUBCUTANEOUS | AP | 2018-05-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206812-004 | FONDAPARINUX SODIUM | 10MG/0.8ML | INJECTABLE / SUBCUTANEOUS | AP | 2018-05-15 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206812-001 | FONDAPARINUX SODIUM | 2.5MG/0.5ML | INJECTABLE / SUBCUTANEOUS | AP | 2018-05-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206812-002 | FONDAPARINUX SODIUM | 5MG/0.4ML | INJECTABLE / SUBCUTANEOUS | AP | 2018-05-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206812-003 | FONDAPARINUX SODIUM | 7.5MG/0.6ML | INJECTABLE / SUBCUTANEOUS | AP | 2018-05-15 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206812-004 | FONDAPARINUX SODIUM | 10MG/0.8ML | INJECTABLE / SUBCUTANEOUS | AP | 2018-05-15 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206812-001 | FONDAPARINUX SODIUM | 2.5MG/0.5ML | INJECTABLE / SUBCUTANEOUS | AP | 2018-05-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206812-002 | FONDAPARINUX SODIUM | 5MG/0.4ML | INJECTABLE / SUBCUTANEOUS | AP | 2018-05-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206812-003 | FONDAPARINUX SODIUM | 7.5MG/0.6ML | INJECTABLE / SUBCUTANEOUS | AP | 2018-05-15 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206812-004 | FONDAPARINUX SODIUM | 10MG/0.8ML | INJECTABLE / SUBCUTANEOUS | AP | 2018-05-15 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206812-001 | FONDAPARINUX SODIUM | 2.5MG/0.5ML | INJECTABLE / SUBCUTANEOUS | AP | 2018-05-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206812-002 | FONDAPARINUX SODIUM | 5MG/0.4ML | INJECTABLE / SUBCUTANEOUS | AP | 2018-05-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206812-003 | FONDAPARINUX SODIUM | 7.5MG/0.6ML | INJECTABLE / SUBCUTANEOUS | AP | 2018-05-15 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206812-004 | FONDAPARINUX SODIUM | 10MG/0.8ML | INJECTABLE / SUBCUTANEOUS | AP | 2018-05-15 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206812-001 | FONDAPARINUX SODIUM | 2.5MG/0.5ML | INJECTABLE / SUBCUTANEOUS | AP | 2018-05-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206812-002 | FONDAPARINUX SODIUM | 5MG/0.4ML | INJECTABLE / SUBCUTANEOUS | AP | 2018-05-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206812-003 | FONDAPARINUX SODIUM | 7.5MG/0.6ML | INJECTABLE / SUBCUTANEOUS | AP | 2018-05-15 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206812-004 | FONDAPARINUX SODIUM | 10MG/0.8ML | INJECTABLE / SUBCUTANEOUS | AP | 2018-05-15 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206812-001 | FONDAPARINUX SODIUM | 2.5MG/0.5ML | INJECTABLE / SUBCUTANEOUS | AP | 2018-05-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206812-002 | FONDAPARINUX SODIUM | 5MG/0.4ML | INJECTABLE / SUBCUTANEOUS | AP | 2018-05-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206812-003 | FONDAPARINUX SODIUM | 7.5MG/0.6ML | INJECTABLE / SUBCUTANEOUS | AP | 2018-05-15 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206812-004 | FONDAPARINUX SODIUM | 10MG/0.8ML | INJECTABLE / SUBCUTANEOUS | AP | 2018-05-15 | d8e5a09893c0… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A206812-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206812-002 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206812-003 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206812-004 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206812-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206812-002 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206812-003 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206812-004 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A206812-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206812-002 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206812-003 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206812-004 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206812-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206812-002 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206812-003 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206812-004 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206812-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206812-002 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206812-003 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206812-004 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206812-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206812-002 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206812-003 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206812-004 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206812-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206812-002 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206812-003 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206812-004 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206812-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206812-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206812-003 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206812-004 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206812-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206812-002 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206812-003 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206812-004 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A206812-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A206812-002 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A206812-003 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A206812-004 | AP | 1 | d06236e962d9… |
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 |
|---|---|---|---|---|---|---|
| Fondaparinux Sodium | FONDAPARINUX SODIUM | Sandoz Inc. | baa50757-a927-4d56-a933-5d7798fe6ab0 | 2025-08-27 | Boxed warning, Warnings, Adverse reactions | 206812 ANDA206812 0781-3476 0781-3454 0781-3443 0781-3465 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0781-3443 | Fondaparinux Sodium | Fondaparinux Sodium | Sandoz Inc. | ANDA | Current |
| 0781-3443 | Fondaparinux Sodium | Fondaparinux Sodium | Sandoz Inc. | ANDA | Current |
| 0781-3443 | Fondaparinux Sodium | Fondaparinux Sodium | Sandoz Inc. | ANDA | Current |
| 0781-3443 | Fondaparinux Sodium | Fondaparinux Sodium | Sandoz Inc. | ANDA | Current |
| 0781-3443 | Fondaparinux Sodium | Fondaparinux Sodium | Sandoz Inc. | ANDA | Current |
| 0781-3443 | Fondaparinux Sodium | Fondaparinux Sodium | Sandoz Inc. | ANDA | Current |
| 0781-3443 | Fondaparinux Sodium | Fondaparinux Sodium | Sandoz Inc. | ANDA | Current |
| 0781-3454 | Fondaparinux Sodium | Fondaparinux Sodium | Sandoz Inc. | ANDA | Current |
| 0781-3454 | Fondaparinux Sodium | Fondaparinux Sodium | Sandoz Inc. | ANDA | Current |
| 0781-3454 | Fondaparinux Sodium | Fondaparinux Sodium | Sandoz Inc. | ANDA | Current |
| 0781-3454 | Fondaparinux Sodium | Fondaparinux Sodium | Sandoz Inc. | ANDA | Current |
| 0781-3454 | Fondaparinux Sodium | Fondaparinux Sodium | Sandoz Inc. | ANDA | Current |
| 0781-3454 | Fondaparinux Sodium | Fondaparinux Sodium | Sandoz Inc. | ANDA | Current |
| 0781-3454 | Fondaparinux Sodium | Fondaparinux Sodium | Sandoz Inc. | ANDA | Current |
| 0781-3465 | Fondaparinux Sodium | Fondaparinux Sodium | Sandoz Inc. | ANDA | Current |
| 0781-3465 | Fondaparinux Sodium | Fondaparinux Sodium | Sandoz Inc. | ANDA | Current |
| 0781-3465 | Fondaparinux Sodium | Fondaparinux Sodium | Sandoz Inc. | ANDA | Current |
| 0781-3465 | Fondaparinux Sodium | Fondaparinux Sodium | Sandoz Inc. | ANDA | Current |
| 0781-3465 | Fondaparinux Sodium | Fondaparinux Sodium | Sandoz Inc. | ANDA | Current |
| 0781-3465 | Fondaparinux Sodium | Fondaparinux Sodium | Sandoz Inc. | ANDA | Current |
| 0781-3465 | Fondaparinux Sodium | Fondaparinux Sodium | Sandoz Inc. | ANDA | Current |
| 0781-3476 | Fondaparinux Sodium | Fondaparinux Sodium | Sandoz Inc. | ANDA | Current |
| 0781-3476 | Fondaparinux Sodium | Fondaparinux Sodium | Sandoz Inc. | ANDA | Current |
| 0781-3476 | Fondaparinux Sodium | Fondaparinux Sodium | Sandoz Inc. | ANDA | Current |
| 0781-3476 | Fondaparinux Sodium | Fondaparinux Sodium | Sandoz Inc. | ANDA | Current |
| 0781-3476 | Fondaparinux Sodium | Fondaparinux Sodium | Sandoz Inc. | ANDA | Current |
| 0781-3476 | Fondaparinux Sodium | Fondaparinux Sodium | Sandoz Inc. | ANDA | Current |
| 0781-3476 | Fondaparinux Sodium | Fondaparinux Sodium | Sandoz Inc. | ANDA | Current |