Application 205660
- Type
- ANDA
- Sponsor
- SHENZHEN TECHDOW
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 30MG/0.3ML (100MG/ML) | No | No |
| 002 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 40MG/0.4ML (100MG/ML) | No | No |
| 003 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 60MG/0.6ML (100MG/ML) | No | No |
| 004 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 80MG/0.8ML (100MG/ML) | No | No |
| 005 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 100MG/ML (100MG/ML) | No | No |
| 006 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 120MG/0.8ML (150MG/ML) | No | No |
| 007 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 150MG/ML (150MG/ML) | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A205660-001 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 30MG/0.3ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2023-03-15 | |
| A205660-002 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 40MG/0.4ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2023-03-15 | |
| A205660-003 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 60MG/0.6ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2023-03-15 | |
| A205660-004 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 80MG/0.8ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2023-03-15 | |
| A205660-005 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 100MG/ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2023-03-15 | |
| A205660-006 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 120MG/0.8ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2023-03-15 | |
| A205660-007 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 150MG/ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2023-03-15 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A205660-001 | AP |
| A205660-002 | AP |
| A205660-003 | AP |
| A205660-004 | AP |
| A205660-005 | AP |
| A205660-006 | AP |
| A205660-007 | AP |
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 | A205660-001 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 30MG/0.3ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2023-03-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A205660-002 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 40MG/0.4ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2023-03-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A205660-003 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 60MG/0.6ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2023-03-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A205660-004 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 80MG/0.8ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2023-03-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A205660-005 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 100MG/ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2023-03-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A205660-006 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 120MG/0.8ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2023-03-15 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A205660-007 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 150MG/ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2023-03-15 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A205660-001 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 30MG/0.3ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2023-03-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A205660-002 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 40MG/0.4ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2023-03-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A205660-003 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 60MG/0.6ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2023-03-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A205660-004 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 80MG/0.8ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2023-03-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A205660-005 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 100MG/ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2023-03-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A205660-006 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 120MG/0.8ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2023-03-15 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A205660-007 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 150MG/ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2023-03-15 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205660-001 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 30MG/0.3ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2023-03-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205660-002 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 40MG/0.4ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2023-03-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205660-003 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 60MG/0.6ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2023-03-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205660-004 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 80MG/0.8ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2023-03-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205660-005 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 100MG/ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2023-03-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205660-006 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 120MG/0.8ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2023-03-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205660-007 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 150MG/ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2023-03-15 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205660-001 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 30MG/0.3ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2023-03-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205660-002 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 40MG/0.4ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2023-03-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205660-003 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 60MG/0.6ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2023-03-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205660-004 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 80MG/0.8ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2023-03-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205660-005 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 100MG/ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2023-03-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205660-006 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 120MG/0.8ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2023-03-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205660-007 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 150MG/ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2023-03-15 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205660-001 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 30MG/0.3ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2023-03-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205660-002 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 40MG/0.4ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2023-03-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205660-003 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 60MG/0.6ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2023-03-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205660-004 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 80MG/0.8ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2023-03-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205660-005 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 100MG/ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2023-03-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205660-006 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 120MG/0.8ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2023-03-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205660-007 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 150MG/ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2023-03-15 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205660-001 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 30MG/0.3ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2023-03-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205660-002 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 40MG/0.4ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2023-03-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205660-003 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 60MG/0.6ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2023-03-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205660-004 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 80MG/0.8ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2023-03-15 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205660-005 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 100MG/ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2023-03-15 | fd3edfee7708… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A205660-001 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A205660-002 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A205660-003 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A205660-004 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A205660-005 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A205660-006 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A205660-007 | AP | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A205660-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A205660-002 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A205660-003 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A205660-004 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A205660-005 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A205660-006 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A205660-007 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A205660-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205660-002 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205660-003 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205660-004 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205660-005 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205660-006 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A205660-007 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205660-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205660-002 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205660-003 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205660-004 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205660-005 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205660-006 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205660-007 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A205660-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205660-002 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205660-003 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205660-004 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205660-005 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205660-006 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A205660-007 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205660-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205660-002 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205660-003 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205660-004 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205660-005 | AP | 1 | fd3edfee7708… |
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 |
|---|---|---|---|---|---|---|
| Enoxaparin Sodium | ENOXAPARIN SODIUM | Hepalink USA Inc. | 31e7c4d0-ba45-4b20-8e25-2d12892372e5 | 2026-01-21 | Boxed warning, Warnings, Adverse reactions | 205660 ANDA205660 |
| Enoxaparin Sodium | ENOXAPARIN SODIUM | NorthStar RxLLC | 014c6710-f2c4-fd1e-e063-6394a90ae525 | 2024-06-21 | Boxed warning, Warnings, Adverse reactions | 205660 ANDA205660 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.