Application 020164
- Type
- NDA
- Sponsor
- SANOFI AVENTIS US
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 30MG/0.3ML (100MG/ML) | Yes | No |
| 002 | LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 40MG/0.4ML (100MG/ML) | Yes | No |
| 003 | LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 60MG/0.6ML (100MG/ML) | Yes | No |
| 004 | LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 80MG/0.8ML (100MG/ML) | Yes | No |
| 005 | LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 100MG/ML (100MG/ML) | Yes | Yes |
| 006 | LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 90MG/0.6ML (150MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 007 | LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 120MG/0.8ML (150MG/ML) | Yes | No |
| 008 | LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | INJECTABLE;SUBCUTANEOUS | 150MG/ML (150MG/ML) | Yes | No |
| 009 | LOVENOX | ENOXAPARIN SODIUM | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 300MG/3ML (100MG/ML) | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020164-001 | LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 30MG/0.3ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD | 1993-03-29 |
| N020164-002 | LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 40MG/0.4ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD | 1998-01-30 |
| N020164-003 | LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 60MG/0.6ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD | 1998-03-27 |
| N020164-004 | LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 80MG/0.8ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD | 1998-03-27 |
| N020164-005 | LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 100MG/ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 1998-03-27 |
| N020164-006 | LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 90MG/0.6ML (150MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / SUBCUTANEOUS | RLD | 2000-06-02 | |
| N020164-007 | LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 120MG/0.8ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD | 2000-06-02 |
| N020164-008 | LOVENOX (PRESERVATIVE FREE) | ENOXAPARIN SODIUM | 150MG/ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD | 2000-06-02 |
| N020164-009 | LOVENOX | ENOXAPARIN SODIUM | 300MG/3ML (100MG/ML) | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AB | RLD | 2003-01-23 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N020164-001 | AP |
| N020164-002 | AP |
| N020164-003 | AP |
| N020164-004 | AP |
| N020164-005 | AP |
| N020164-007 | AP |
| N020164-008 | AP |
| N020164-009 | AB |
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 | N020164-001 | LOVENOX (PRESERVATIVE FREE) | 30MG/0.3ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD | 1993-03-29 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020164-002 | LOVENOX (PRESERVATIVE FREE) | 40MG/0.4ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD | 1998-01-30 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020164-003 | LOVENOX (PRESERVATIVE FREE) | 60MG/0.6ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD | 1998-03-27 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020164-004 | LOVENOX (PRESERVATIVE FREE) | 80MG/0.8ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD | 1998-03-27 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020164-005 | LOVENOX (PRESERVATIVE FREE) | 100MG/ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 1998-03-27 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020164-006 | LOVENOX (PRESERVATIVE FREE) | 90MG/0.6ML (150MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / SUBCUTANEOUS | RLD | 2000-06-02 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020164-007 | LOVENOX (PRESERVATIVE FREE) | 120MG/0.8ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD | 2000-06-02 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020164-008 | LOVENOX (PRESERVATIVE FREE) | 150MG/ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD | 2000-06-02 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020164-009 | LOVENOX | 300MG/3ML (100MG/ML) | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AB | RLD | 2003-01-23 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N020164-001 | LOVENOX (PRESERVATIVE FREE) | 30MG/0.3ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD | 1993-03-29 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020164-002 | LOVENOX (PRESERVATIVE FREE) | 40MG/0.4ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD | 1998-01-30 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020164-003 | LOVENOX (PRESERVATIVE FREE) | 60MG/0.6ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD | 1998-03-27 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020164-004 | LOVENOX (PRESERVATIVE FREE) | 80MG/0.8ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD | 1998-03-27 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020164-005 | LOVENOX (PRESERVATIVE FREE) | 100MG/ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 1998-03-27 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020164-006 | LOVENOX (PRESERVATIVE FREE) | 90MG/0.6ML (150MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / SUBCUTANEOUS | RLD | 2000-06-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020164-007 | LOVENOX (PRESERVATIVE FREE) | 120MG/0.8ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD | 2000-06-02 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020164-008 | LOVENOX (PRESERVATIVE FREE) | 150MG/ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD | 2000-06-02 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020164-009 | LOVENOX | 300MG/3ML (100MG/ML) | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AB | RLD | 2003-01-23 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020164-001 | LOVENOX (PRESERVATIVE FREE) | 30MG/0.3ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD | 1993-03-29 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020164-002 | LOVENOX (PRESERVATIVE FREE) | 40MG/0.4ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD | 1998-01-30 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020164-003 | LOVENOX (PRESERVATIVE FREE) | 60MG/0.6ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD | 1998-03-27 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020164-004 | LOVENOX (PRESERVATIVE FREE) | 80MG/0.8ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD | 1998-03-27 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020164-005 | LOVENOX (PRESERVATIVE FREE) | 100MG/ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 1998-03-27 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020164-006 | LOVENOX (PRESERVATIVE FREE) | 90MG/0.6ML (150MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / SUBCUTANEOUS | RLD | 2000-06-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020164-007 | LOVENOX (PRESERVATIVE FREE) | 120MG/0.8ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD | 2000-06-02 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020164-008 | LOVENOX (PRESERVATIVE FREE) | 150MG/ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD | 2000-06-02 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020164-009 | LOVENOX | 300MG/3ML (100MG/ML) | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AB | RLD | 2003-01-23 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N020164-001 | LOVENOX (PRESERVATIVE FREE) | 30MG/0.3ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD | 1993-03-29 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020164-002 | LOVENOX (PRESERVATIVE FREE) | 40MG/0.4ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD | 1998-01-30 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020164-003 | LOVENOX (PRESERVATIVE FREE) | 60MG/0.6ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD | 1998-03-27 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020164-004 | LOVENOX (PRESERVATIVE FREE) | 80MG/0.8ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD | 1998-03-27 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020164-005 | LOVENOX (PRESERVATIVE FREE) | 100MG/ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD, RS | 1998-03-27 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020164-006 | LOVENOX (PRESERVATIVE FREE) | 90MG/0.6ML (150MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / SUBCUTANEOUS | RLD | 2000-06-02 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020164-007 | LOVENOX (PRESERVATIVE FREE) | 120MG/0.8ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD | 2000-06-02 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020164-008 | LOVENOX (PRESERVATIVE FREE) | 150MG/ML (150MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD | 2000-06-02 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020164-009 | LOVENOX | 300MG/3ML (100MG/ML) | INJECTABLE / INTRAVENOUS, SUBCUTANEOUS | AB | RLD | 2003-01-23 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020164-001 | LOVENOX (PRESERVATIVE FREE) | 30MG/0.3ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD | 1993-03-29 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020164-002 | LOVENOX (PRESERVATIVE FREE) | 40MG/0.4ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD | 1998-01-30 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020164-003 | LOVENOX (PRESERVATIVE FREE) | 60MG/0.6ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD | 1998-03-27 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020164-004 | LOVENOX (PRESERVATIVE FREE) | 80MG/0.8ML (100MG/ML) | INJECTABLE / SUBCUTANEOUS | AP | RLD | 1998-03-27 | fd3edfee7708… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N020164-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020164-002 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020164-003 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020164-004 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020164-005 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020164-007 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020164-008 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020164-009 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N020164-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020164-002 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020164-003 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020164-004 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020164-005 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020164-007 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020164-008 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020164-009 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020164-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020164-002 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020164-003 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020164-004 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020164-005 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020164-007 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020164-008 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020164-009 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N020164-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020164-002 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020164-003 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020164-004 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020164-005 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020164-007 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020164-008 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020164-009 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020164-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020164-002 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020164-003 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020164-004 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020164-005 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020164-007 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020164-008 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020164-009 | AB | 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 |
|---|---|---|---|---|---|---|
| Lovenox | ENOXAPARIN SODIUM | Sanofi-Aventis U.S. LLC | 5017a927-2a24-4f27-89f9-27c805bf7d59 | 2026-05-28 | Boxed warning, Warnings, Adverse reactions | 020164 NDA020164 0075-2915 0075-0626 0075-0624 0075-0622 0075-0621 0075-0623 0075-2912 0075-0620 |
| Lovenox | ENOXAPARIN SODIUM | Cardinal Health 107, LLC | 3d263380-4f44-4fd8-aa2a-e69702ab258f | 2026-04-27 | Boxed warning, Warnings, Adverse reactions | 020164 NDA020164 |
| Lovenox | ENOXAPARIN SODIUM | Sanofi-Aventis U.S. LLC | de6fb917-a94a-41ea-9d7d-937d4080ffcd | 2026-02-06 | Boxed warning, Warnings, Adverse reactions | 020164 NDA020164 0075-8020 0075-8025 0075-8016 0075-8013 0075-8022 0075-8014 0075-8018 |
| Enoxaparin sodium | ENOXAPARIN SODIUM | Sanofi-Aventis U.S. LLC | 20635579-c92d-4f6c-a332-1096d51002f2 | 2026-02-06 | Boxed warning, Warnings, Adverse reactions | 020164 NDA020164 |
| Enoxaparin Sodium | ENOXAPARIN SODIUM | Fresenius Kabi USA, LLC | 21b095d1-5ade-43e9-9114-30fbfb2331c9 | 2026-02-04 | Boxed warning, Warnings, Adverse reactions | 020164 NDA020164 |
| Enoxaparin Sodium | ENOXAPARIN SODIUM | Fresenius Kabi USA, LLC | 066f27ec-352c-4051-ba29-248e292690db | 2026-02-04 | Boxed warning, Warnings, Adverse reactions | 020164 NDA020164 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0075-0620 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-0620 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-0620 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-0620 | Lovenox | enoxaparin sodium | sanofi-aventis U.S. LLC | NDA | Current |
| 0075-0620 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-0620 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-0621 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-0621 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-0621 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-0621 | Lovenox | enoxaparin sodium | sanofi-aventis U.S. LLC | NDA | Current |
| 0075-0621 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-0621 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-0622 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-0622 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-0622 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-0622 | Lovenox | enoxaparin sodium | sanofi-aventis U.S. LLC | NDA | Current |
| 0075-0622 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-0622 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-0623 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-0623 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-0623 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-0623 | Lovenox | enoxaparin sodium | sanofi-aventis U.S. LLC | NDA | Current |
| 0075-0623 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-0623 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-0624 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-0624 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-0624 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-0624 | Lovenox | enoxaparin sodium | sanofi-aventis U.S. LLC | NDA | Current |
| 0075-0624 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-0624 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-0626 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-0626 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-0626 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-0626 | Lovenox | enoxaparin sodium | sanofi-aventis U.S. LLC | NDA | Current |
| 0075-0626 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-0626 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-2912 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-2912 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-2912 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-2912 | Lovenox | enoxaparin sodium | sanofi-aventis U.S. LLC | NDA | Current |
| 0075-2912 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-2912 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-2915 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-2915 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-2915 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-2915 | Lovenox | enoxaparin sodium | sanofi-aventis U.S. LLC | NDA | Current |
| 0075-2915 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-2915 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-8013 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-8013 | Lovenox | enoxaparin sodium | sanofi-aventis U.S. LLC | NDA | Current |
| 0075-8013 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-8013 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-8013 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-8014 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-8014 | Lovenox | enoxaparin sodium | sanofi-aventis U.S. LLC | NDA | Current |
| 0075-8014 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-8014 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-8014 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-8016 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-8016 | Lovenox | enoxaparin sodium | sanofi-aventis U.S. LLC | NDA | Current |
| 0075-8016 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-8016 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-8016 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-8018 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-8018 | Lovenox | enoxaparin sodium | sanofi-aventis U.S. LLC | NDA | Current |
| 0075-8018 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-8018 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-8018 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-8020 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-8020 | Lovenox | enoxaparin sodium | sanofi-aventis U.S. LLC | NDA | Current |
| 0075-8020 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-8020 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-8020 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-8022 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-8022 | Lovenox | enoxaparin sodium | sanofi-aventis U.S. LLC | NDA | Current |
| 0075-8022 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-8022 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-8022 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-8025 | Lovenox | enoxaparin sodium | Sanofi-Aventis U.S. LLC | NDA | Current |
| 0075-8025 | Lovenox | enoxaparin sodium | sanofi-aventis U.S. LLC | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 74941 | SUPPL | 2023-07-31 |
| 74940 | SUPPL | 2023-07-31 |
| 72775 | SUPPL | 2022-12-05 |
| 72770 | SUPPL | 2022-12-02 |
| 69729 | SUPPL | 2021-12-21 |
| 69699 | SUPPL | 2021-12-20 |
| 56839 | SUPPL | 2018-12-20 |
| 56710 | SUPPL | 2018-12-12 |
| 50280 | SUPPL | 2017-11-03 |
| 50238 | SUPPL | 2017-10-31 |
| 44049 | ORIG | 2013-11-07 |
| 34335 | SUPPL | 2013-10-31 |
| 21249 | SUPPL | 2013-10-25 |
| 34334 | SUPPL | 2013-06-11 |
| 2128 | SUPPL | 2013-06-07 |
| 2127 | SUPPL | 2011-04-22 |
| 12290 | SUPPL | 2011-04-21 |
| 34333 | SUPPL | 2011-04-19 |
| 2126 | SUPPL | 2011-04-15 |
| 21248 | SUPPL | 2009-12-31 |
| 12289 | SUPPL | 2009-12-30 |
| 21247 | SUPPL | 2009-07-31 |
| 34332 | SUPPL | 2009-07-30 |
| 20515 | SUPPL | 2009-03-24 |
| 41182 | SUPPL | 2008-08-11 |
| 20506 | SUPPL | 2008-08-11 |
| 20505 | SUPPL | 2008-08-11 |
| 20504 | SUPPL | 2008-08-11 |
| 20503 | SUPPL | 2008-08-11 |
| 41188 | SUPPL | 2008-08-08 |
| 41187 | SUPPL | 2008-08-08 |
| 41186 | SUPPL | 2008-08-08 |
| 41184 | SUPPL | 2008-08-08 |
| 20509 | SUPPL | 2008-08-08 |
| 20508 | SUPPL | 2008-08-08 |
| 20507 | SUPPL | 2008-08-08 |
| 41197 | SUPPL | 2008-08-04 |
| 41196 | SUPPL | 2008-08-04 |
| 41195 | SUPPL | 2008-08-04 |
| 41194 | SUPPL | 2008-08-04 |
| 41193 | SUPPL | 2008-08-04 |
| 41192 | SUPPL | 2008-08-04 |
| 41191 | SUPPL | 2008-08-04 |
| 41190 | SUPPL | 2008-08-04 |
| 41189 | SUPPL | 2008-08-04 |
| 20511 | SUPPL | 2008-08-04 |
| 41198 | SUPPL | 2008-08-01 |
| 20514 | SUPPL | 2008-08-01 |
| 20512 | SUPPL | 2008-08-01 |
| 20510 | SUPPL | 2008-08-01 |
| 12288 | SUPPL | 2008-07-22 |
| 21246 | SUPPL | 2008-07-18 |
| 41200 | SUPPL | 2007-07-09 |
| 41199 | SUPPL | 2007-07-09 |
| 21245 | SUPPL | 2007-05-29 |
| 12287 | SUPPL | 2007-05-29 |
| 34331 | SUPPL | 2007-01-16 |
| 2125 | SUPPL | 2007-01-16 |
| 20513 | SUPPL | 2006-10-26 |
| 2124 | SUPPL | 2005-03-10 |
| 21241 | SUPPL | 2004-10-26 |
| 21242 | SUPPL | 2004-07-28 |
| 12286 | SUPPL | 2004-07-28 |
| 20502 | ORIG | 2004-07-15 |
| 2114 | SUPPL | 2004-06-08 |
| 2123 | SUPPL | 2004-05-26 |
| 21244 | SUPPL | 2004-04-29 |
| 21243 | SUPPL | 2004-04-20 |
| 34328 | ORIG | 2004-04-05 |
| 21236 | ORIG | 2004-02-25 |
| 2120 | SUPPL | 2003-12-23 |
| 2121 | SUPPL | 2003-07-08 |
| 2122 | SUPPL | 2003-07-06 |
| 41183 | SUPPL | 2003-04-29 |
| 21239 | SUPPL | 2003-01-23 |
| 21240 | SUPPL | 2002-01-09 |
| 21238 | SUPPL | 2002-01-09 |
| 2119 | SUPPL | 2002-01-09 |
| 34330 | SUPPL | 2000-11-17 |
| 21237 | SUPPL | 2000-11-17 |
| 12285 | SUPPL | 2000-11-17 |
| 2118 | SUPPL | 2000-11-17 |
| 2117 | SUPPL | 2000-09-27 |
| 2116 | SUPPL | 2000-08-04 |
| 41185 | SUPPL | 2000-07-03 |
| 34329 | SUPPL | 1998-12-31 |
| 2115 | SUPPL | 1998-12-31 |