Application 218775
- Type
- ANDA
- Sponsor
- HEBEI CHANGSHAN
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 |
|---|---|---|---|---|---|---|---|
| A218775-001 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 30MG/0.3ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2026-01-07 | |
| A218775-002 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 40MG/0.4ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2026-01-07 | |
| A218775-003 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 60MG/0.6ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2026-01-07 | |
| A218775-004 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 80MG/0.8ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2026-01-07 | |
| A218775-005 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 100MG/ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2026-01-07 | |
| A218775-006 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 120MG/0.8ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2026-01-07 | |
| A218775-007 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 150MG/ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2026-01-07 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A218775-001 | AP |
| A218775-002 | AP |
| A218775-003 | AP |
| A218775-004 | AP |
| A218775-005 | AP |
| A218775-006 | AP |
| A218775-007 | 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 | A218775-001 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 30MG/0.3ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2026-01-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A218775-002 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 40MG/0.4ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2026-01-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A218775-003 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 60MG/0.6ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2026-01-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A218775-004 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 80MG/0.8ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2026-01-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A218775-005 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 100MG/ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2026-01-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A218775-006 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 120MG/0.8ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2026-01-07 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A218775-007 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 150MG/ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2026-01-07 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A218775-001 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 30MG/0.3ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2026-01-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A218775-002 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 40MG/0.4ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2026-01-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A218775-003 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 60MG/0.6ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2026-01-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A218775-004 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 80MG/0.8ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2026-01-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A218775-005 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 100MG/ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2026-01-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A218775-006 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 120MG/0.8ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2026-01-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A218775-007 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 150MG/ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2026-01-07 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218775-001 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 30MG/0.3ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2026-01-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218775-002 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 40MG/0.4ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2026-01-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218775-003 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 60MG/0.6ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2026-01-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218775-004 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 80MG/0.8ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2026-01-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218775-005 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 100MG/ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2026-01-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218775-006 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 120MG/0.8ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2026-01-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218775-007 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 150MG/ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2026-01-07 | 011fe1cb6892… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218775-001 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 30MG/0.3ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2026-01-07 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218775-002 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 40MG/0.4ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2026-01-07 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218775-003 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 60MG/0.6ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2026-01-07 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218775-004 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 80MG/0.8ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2026-01-07 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218775-005 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 100MG/ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2026-01-07 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218775-006 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 120MG/0.8ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2026-01-07 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218775-007 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 150MG/ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2026-01-07 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A218775-001 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A218775-002 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A218775-003 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A218775-004 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A218775-005 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A218775-006 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A218775-007 | AP | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A218775-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A218775-002 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A218775-003 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A218775-004 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A218775-005 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A218775-006 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A218775-007 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A218775-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A218775-002 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A218775-003 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A218775-004 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A218775-005 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A218775-006 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A218775-007 | AP | 1 | 011fe1cb6892… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218775-001 | AP | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218775-002 | AP | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218775-003 | AP | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218775-004 | AP | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218775-005 | AP | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218775-006 | AP | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218775-007 | AP | 1 | a50c72e98297… |
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 | Hebei Changshan Biochemical Pharmaceutical Co., Ltd. | 7fa78f8d-92d9-434a-8e26-b886ab0ae77f | 2026-01-14 | Boxed warning, Warnings, Adverse reactions | 218775 ANDA218775 |