Application 017037
- Type
- NDA
- Sponsor
- HIKMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | HEPARIN SODIUM | HEPARIN SODIUM | INJECTABLE;INJECTION | 1,000 UNITS/ML | Yes | Yes |
| 002 | HEPARIN SODIUM | HEPARIN SODIUM | INJECTABLE;INJECTION | 5,000 UNITS/ML | Yes | Yes |
| 003 | HEPARIN SODIUM | HEPARIN SODIUM | INJECTABLE;INJECTION | 10,000 UNITS/ML | Yes | Yes |
| 013 | HEPARIN SODIUM | HEPARIN SODIUM | INJECTABLE;INJECTION | 5,000 UNITS/0.5ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N017037-001 | HEPARIN SODIUM | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | |
| N017037-002 | HEPARIN SODIUM | HEPARIN SODIUM | 5,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | |
| N017037-003 | HEPARIN SODIUM | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | |
| N017037-013 | HEPARIN SODIUM | HEPARIN SODIUM | 5,000 UNITS/0.5ML | INJECTABLE / INJECTION | 1986-04-07 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N017037-001 | AP |
| N017037-002 | AP |
| N017037-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N017037-001 | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N017037-002 | HEPARIN SODIUM | 5,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N017037-003 | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N017037-013 | HEPARIN SODIUM | 5,000 UNITS/0.5ML | INJECTABLE / INJECTION | 1986-04-07 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N017037-001 | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N017037-002 | HEPARIN SODIUM | 5,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N017037-003 | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N017037-013 | HEPARIN SODIUM | 5,000 UNITS/0.5ML | INJECTABLE / INJECTION | 1986-04-07 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017037-001 | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017037-002 | HEPARIN SODIUM | 5,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017037-003 | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017037-013 | HEPARIN SODIUM | 5,000 UNITS/0.5ML | INJECTABLE / INJECTION | 1986-04-07 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N017037-001 | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N017037-002 | HEPARIN SODIUM | 5,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N017037-003 | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N017037-013 | HEPARIN SODIUM | 5,000 UNITS/0.5ML | INJECTABLE / INJECTION | 1986-04-07 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017037-001 | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017037-002 | HEPARIN SODIUM | 5,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017037-003 | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017037-013 | HEPARIN SODIUM | 5,000 UNITS/0.5ML | INJECTABLE / INJECTION | 1986-04-07 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017037-001 | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017037-002 | HEPARIN SODIUM | 5,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017037-003 | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017037-013 | HEPARIN SODIUM | 5,000 UNITS/0.5ML | INJECTABLE / INJECTION | 1986-04-07 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017037-001 | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017037-002 | HEPARIN SODIUM | 5,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017037-003 | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017037-013 | HEPARIN SODIUM | 5,000 UNITS/0.5ML | INJECTABLE / INJECTION | AP | 1986-04-07 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017037-001 | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017037-002 | HEPARIN SODIUM | 5,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017037-003 | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017037-013 | HEPARIN SODIUM | 5,000 UNITS/0.5ML | INJECTABLE / INJECTION | AP | 1986-04-07 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017037-001 | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017037-002 | HEPARIN SODIUM | 5,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017037-003 | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017037-013 | HEPARIN SODIUM | 5,000 UNITS/0.5ML | INJECTABLE / INJECTION | AP | 1986-04-07 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N017037-001 | HEPARIN SODIUM | 1,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N017037-002 | HEPARIN SODIUM | 5,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N017037-003 | HEPARIN SODIUM | 10,000 UNITS/ML | INJECTABLE / INJECTION | AP | RLD, RS, Approved before 1982 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N017037-013 | HEPARIN SODIUM | 5,000 UNITS/0.5ML | INJECTABLE / INJECTION | AP | 1986-04-07 | d8e5a09893c0… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N017037-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N017037-002 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N017037-003 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N017037-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N017037-002 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N017037-003 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017037-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017037-002 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017037-003 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N017037-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N017037-002 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N017037-003 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017037-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017037-002 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017037-003 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017037-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017037-002 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017037-003 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017037-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017037-002 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017037-003 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017037-013 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017037-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017037-002 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017037-003 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017037-013 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017037-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017037-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017037-003 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017037-013 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N017037-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N017037-002 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N017037-003 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N017037-013 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N017037-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N017037-002 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N017037-003 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N017037-013 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N017037-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N017037-002 | AP | 1 | 79d66fd596c7… |
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 |
|---|---|---|---|---|---|---|
| Heparin Sodium | HEPARIN SODIUM | Cardinal Health 107, LLC | 62cfd1bb-894f-4429-b362-1e40981dccc6 | 2026-06-11 | Warnings, Adverse reactions | 017037 NDA017037 55154-5130 |
| Heparin Sodium | HEPARIN SODIUM | REMEDYREPACK INC. | a5fab0b1-c472-489c-ba87-2f8e53356173 | 2026-01-16 | Warnings, Adverse reactions | 017037 NDA017037 |
| Heparin Sodium | HEPARIN SODIUM | Hikma Pharmaceuticals USA Inc. | 7014808d-cec9-4b2c-8eb5-940493e356ab | 2025-08-13 | Warnings, Adverse reactions | 017037 NDA017037 0641-2460 0641-0410 0641-6204 0641-6199 0641-2450 0641-0391 0641-0400 |
| Heparin Sodium | HEPARIN SODIUM | Civica, Inc. | 1e362730-5a56-4948-a90f-2cb75fed9e91 | 2025-07-12 | Warnings, Adverse reactions | 017037 NDA017037 72572-255 72572-250 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0641-0391 | Heparin Sodium | Heparin Sodium | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0641-0391 | Heparin Sodium | Heparin Sodium | West-Ward Pharmaceuticals Corp. | NDA | Current |
| 0641-0391 | Heparin Sodium | Heparin Sodium | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0641-0391 | Heparin Sodium | Heparin Sodium | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0641-0391 | Heparin Sodium | Heparin Sodium | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0641-0400 | Heparin Sodium | Heparin Sodium | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0641-0400 | Heparin Sodium | Heparin Sodium | West-Ward Pharmaceuticals Corp. | NDA | Current |
| 0641-0400 | Heparin Sodium | Heparin Sodium | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0641-0400 | Heparin Sodium | Heparin Sodium | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0641-0400 | Heparin Sodium | Heparin Sodium | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0641-0410 | Heparin Sodium | Heparin Sodium | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0641-0410 | Heparin Sodium | Heparin Sodium | West-Ward Pharmaceuticals Corp. | NDA | Current |
| 0641-0410 | Heparin Sodium | Heparin Sodium | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0641-0410 | Heparin Sodium | Heparin Sodium | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0641-0410 | Heparin Sodium | Heparin Sodium | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0641-2450 | Heparin Sodium | Heparin Sodium | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0641-2450 | Heparin Sodium | Heparin Sodium | West-Ward Pharmaceuticals Corp. | NDA | Current |
| 0641-2450 | Heparin Sodium | Heparin Sodium | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0641-2450 | Heparin Sodium | Heparin Sodium | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0641-2450 | Heparin Sodium | Heparin Sodium | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0641-2460 | Heparin Sodium | Heparin Sodium | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0641-2460 | Heparin Sodium | Heparin Sodium | West-Ward Pharmaceuticals Corp. | NDA | Current |
| 0641-2460 | Heparin Sodium | Heparin Sodium | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0641-2460 | Heparin Sodium | Heparin Sodium | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0641-2460 | Heparin Sodium | Heparin Sodium | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0641-6199 | Heparin Sodium | Heparin sodium | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0641-6199 | Heparin Sodium | Heparin sodium | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0641-6199 | Heparin Sodium | Heparin sodium | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0641-6199 | Heparin Sodium | Heparin sodium | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0641-6204 | Heparin Sodium | Heparin Sodium | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 0641-6204 | Heparin Sodium | Heparin Sodium | Hikma Pharmaceuticals USA Inc. | NDA | Current |
| 55154-5130 | Heparin Sodium | Heparin Sodium | Cardinal Health | NDA | Current |
| 55154-5130 | Heparin Sodium | Heparin Sodium | Cardinal Health | NDA | Current |
| 55154-5130 | Heparin Sodium | Heparin Sodium | Cardinal Health 107, LLC | NDA | Current |
| 55154-5130 | Heparin Sodium | Heparin Sodium | Cardinal Health | NDA | Current |
| 55154-5130 | Heparin Sodium | Heparin Sodium | Cardinal Health | NDA | Current |
| 72572-250 | Heparin Sodium | Heparin Sodium | Civica, Inc. | NDA | Current |
| 72572-250 | Heparin Sodium | Heparin Sodium | Civica, Inc. | NDA | Current |
| 72572-255 | Heparin Sodium | Heparin Sodium | Civica, Inc. | NDA | Current |
| 72572-255 | Heparin Sodium | Heparin Sodium | Civica, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 80006 | SUPPL | 2024-10-28 |
| 79992 | SUPPL | 2024-10-25 |
| 62455 | SUPPL | 2020-04-06 |
| 62453 | SUPPL | 2020-04-06 |
| 59471 | SUPPL | 2019-07-26 |
| 48358 | SUPPL | 2017-05-12 |
| 48334 | SUPPL | 2017-05-10 |
| 10954 | SUPPL | 2012-01-26 |
| 13077 | SUPPL | 2011-12-29 |
| 10953 | SUPPL | 2011-03-04 |
| 13076 | SUPPL | 2011-02-28 |
| 13075 | SUPPL | 2009-11-09 |
| 10952 | SUPPL | 2009-10-16 |
| 534 | SUPPL | 2009-02-19 |
| 533 | SUPPL | 2008-01-09 |
| 33220 | SUPPL | 2007-12-21 |
| 13074 | SUPPL | 2006-10-13 |
| 10951 | SUPPL | 2006-10-05 |
| 33219 | SUPPL | 2005-09-07 |
| 33218 | SUPPL | 2005-09-07 |
| 13073 | SUPPL | 2005-09-07 |
| 13072 | SUPPL | 2005-09-07 |
| 10950 | SUPPL | 2005-09-07 |
| 532 | SUPPL | 2005-09-07 |