Application 078990
- Type
- ANDA
- Sponsor
- APOTEX INC
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 |
|---|---|---|---|---|---|---|---|
| A078990-001 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 30MG/0.3ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | |
| A078990-002 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 40MG/0.4ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | |
| A078990-003 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 60MG/0.6ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | |
| A078990-004 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 80MG/0.8ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | |
| A078990-005 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 100MG/ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | |
| A078990-006 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 120MG/0.8ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | |
| A078990-007 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 150MG/ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078990-001 | AP |
| A078990-002 | AP |
| A078990-003 | AP |
| A078990-004 | AP |
| A078990-005 | AP |
| A078990-006 | AP |
| A078990-007 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078990-001 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 30MG/0.3ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078990-002 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 40MG/0.4ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078990-003 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 60MG/0.6ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078990-004 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 80MG/0.8ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078990-005 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 100MG/ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078990-006 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 120MG/0.8ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078990-007 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 150MG/ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078990-001 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 30MG/0.3ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078990-002 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 40MG/0.4ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078990-003 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 60MG/0.6ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078990-004 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 80MG/0.8ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078990-005 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 100MG/ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078990-006 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 120MG/0.8ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078990-007 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 150MG/ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078990-001 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 30MG/0.3ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078990-002 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 40MG/0.4ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078990-003 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 60MG/0.6ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078990-004 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 80MG/0.8ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078990-005 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 100MG/ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078990-006 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 120MG/0.8ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078990-007 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 150MG/ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078990-001 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 30MG/0.3ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078990-002 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 40MG/0.4ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078990-003 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 60MG/0.6ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078990-004 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 80MG/0.8ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078990-005 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 100MG/ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078990-006 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 120MG/0.8ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078990-007 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 150MG/ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078990-001 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 30MG/0.3ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078990-002 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 40MG/0.4ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078990-003 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 60MG/0.6ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078990-004 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 80MG/0.8ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078990-005 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 100MG/ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078990-006 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 120MG/0.8ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078990-007 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 150MG/ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078990-001 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 30MG/0.3ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078990-002 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 40MG/0.4ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078990-003 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 60MG/0.6ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078990-004 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 80MG/0.8ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078990-005 | ENOXAPARIN SODIUM (PRESERVATIVE FREE) | 100MG/ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | 2018-09-28 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078990-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078990-002 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078990-003 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078990-004 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078990-005 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078990-006 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078990-007 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078990-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078990-002 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078990-003 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078990-004 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078990-005 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078990-006 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078990-007 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078990-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078990-002 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078990-003 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078990-004 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078990-005 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078990-006 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078990-007 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078990-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078990-002 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078990-003 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078990-004 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078990-005 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078990-006 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078990-007 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078990-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078990-002 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078990-003 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078990-004 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078990-005 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078990-006 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078990-007 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078990-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078990-002 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078990-003 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078990-004 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078990-005 | AP | 1 | 03ed91905a0d… |
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 | Cardinal Health 107, LLC | 45a66675-b159-42b8-9f18-ff80f28e1503 | 2026-04-27 | Boxed warning, Warnings, Adverse reactions | 078990 ANDA078990 |
| Enoxaparin Sodium | ENOXAPARIN SODIUM | Fresenius Kabi USA, LLC | c3be543e-8aff-4311-bf77-e7a5a814ca6f | 2026-04-09 | Boxed warning, Warnings, Adverse reactions | 078990 ANDA078990 63323-559 63323-584 63323-564 63323-586 63323-566 |
| ENOXAPARIN SODIUM | ENOXAPARIN SODIUM | Gland Pharma Limited | 65025e0d-eb54-4c4e-bd14-f294ce038902 | 2026-01-23 | Boxed warning, Warnings, Adverse reactions | 078990 ANDA078990 |
| Enoxaparin Sodium | ENOXAPARIN SODIUM | Civica, Inc. | b4728749-8453-4f07-9fbc-a1f3e9d2708b | 2025-10-04 | Boxed warning, Warnings, Adverse reactions | 078990 ANDA078990 |
| Enoxaparin Sodium | ENOXAPARIN SODIUM | Fresenius Kabi USA, LLC | a694bbc3-4eb0-4c1e-b4ff-b8abc3e5148e | 2025-03-19 | Boxed warning, Warnings, Adverse reactions | 078990 ANDA078990 63323-589 63323-559 63323-584 63323-564 63323-586 63323-566 63323-655 |
| Enoxaparin Sodium | ENOXAPARIN SODIUM | Sagent Pharmaceuticals | 419a3566-4f67-4c8d-86e5-c00c7ec429e1 | 2023-08-28 | Boxed warning, Warnings, Adverse reactions | 078990 ANDA078990 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 55154-6688 | Enoxaparin Sodium | enoxaparin sodium | Cardinal Health | ANDA | Current |
| 55154-6689 | Enoxaparin Sodium | enoxaparin sodium | Cardinal Health | ANDA | Current |
| 55154-6690 | Enoxaparin Sodium | enoxaparin sodium | Cardinal Health | ANDA | Current |
| 55154-6691 | Enoxaparin Sodium | enoxaparin sodium | Cardinal Health | ANDA | Current |
| 55154-6692 | Enoxaparin Sodium | enoxaparin sodium | Cardinal Health | ANDA | Current |
| 60505-0791 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0791 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0791 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0791 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0792 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0792 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0792 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0792 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0793 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0793 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0793 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0793 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0794 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0794 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0794 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0794 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0795 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0795 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0795 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0795 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0796 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0796 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0796 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0796 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0798 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0798 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0798 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 60505-0798 | Enoxaparin Sodium | enoxaparin sodium | Apotex Corp. | ANDA | Current |
| 63323-559 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-559 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-559 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-559 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-559 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-564 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-564 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-564 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-564 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-564 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-566 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-566 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-566 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-566 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-566 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-584 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-584 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-584 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-584 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-584 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-586 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-586 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-586 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-586 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-586 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-589 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-589 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-589 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-589 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-655 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-655 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-655 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-655 | Enoxaparin Sodium | Enoxaparin Sodium | Fresenius Kabi USA, LLC | ANDA | Current |