Application 019329
- Type
- NDA
- Sponsor
- ABRAXIS PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER | SODIUM CHLORIDE | INJECTABLE;INJECTION | 234MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019329-001 | SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER | SODIUM CHLORIDE | 234MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1987-04-22 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N019329-001 | SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER | 234MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1987-04-22 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N019329-001 | SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER | 234MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1987-04-22 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N019329-001 | SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER | 234MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1987-04-22 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019329-001 | SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER | 234MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1987-04-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019329-001 | SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER | 234MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1987-04-22 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019329-001 | SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER | 234MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1987-04-22 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019329-001 | SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER | 234MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1987-04-22 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019329-001 | SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER | 234MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1987-04-22 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019329-001 | SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER | 234MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1987-04-22 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019329-001 | SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER | 234MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1987-04-22 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019329-001 | SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER | 234MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1987-04-22 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019329-001 | SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER | 234MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1987-04-22 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N019329-001 | SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER | 234MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1987-04-22 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019329-001 | SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER | 234MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1987-04-22 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019329-001 | SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER | 234MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1987-04-22 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019329-001 | SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER | 234MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1987-04-22 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N019329-001 | SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER | 234MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1987-04-22 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019329-001 | SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER | 234MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1987-04-22 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N019329-001 | SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER | 234MG/ML | INJECTABLE / INJECTION | RLD | 1987-04-22 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N019329-001 | SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER | 234MG/ML | INJECTABLE / INJECTION | RLD | 1987-04-22 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N019329-001 | SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER | 234MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1987-04-22 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N019329-001 | SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER | 234MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1987-04-22 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N019329-001 | SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER | 234MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1987-04-22 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019329-001 | SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER | 234MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1987-04-22 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N019329-001 | SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER | 234MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1987-04-22 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N019329-001 | SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER | 234MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1987-04-22 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N019329-001 | SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER | 234MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1987-04-22 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N019329-001 | SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER | 234MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1987-04-22 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N019329-001 | SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER | 234MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1987-04-22 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N019329-001 | SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER | 234MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1987-04-22 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N019329-001 | SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER | 234MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1987-04-22 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N019329-001 | SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER | 234MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1987-04-22 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N019329-001 | SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER | 234MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1987-04-22 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N019329-001 | SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER | 234MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1987-04-22 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N019329-001 | SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER | 234MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1987-04-22 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N019329-001 | SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER | 234MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1987-04-22 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N019329-001 | SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER | 234MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1987-04-22 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N019329-001 | SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER | 234MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1987-04-22 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N019329-001 | SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER | 234MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1987-04-22 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N019329-001 | SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER | 234MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1987-04-22 | 3a93d1ddd44b… |
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 |
|---|---|---|---|---|---|---|
| Sodium Chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | ed8fd0c1-ac42-4267-877e-ceadf3831c90 | 2021-04-29 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Sodium Chloride | SODIUM CHLORIDE | Medical Purchasing Solutions, LLC | c3f8e83c-4fb9-91da-e053-2a95a90abd63 | 2021-04-12 | Adverse reactions | SODIUM CHLORIDE |
| CVS Health Sterile Saline Mist Live Better | SODIUM CHLORIDE | CVS Pharmacy | ccc3ab8c-b22f-420d-869b-f2a65b8c7180 | 2021-03-13 | Warnings | SODIUM CHLORIDE |
| SODIUM CHLORIDE | SODIUM CHLORIDE | Baxter Healthcare Corporation | aeaed9cb-b629-4019-88d2-a916179427de | 2021-02-19 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Sodium Chloride | SODIUM CHLORIDE | Asclemed USA, Inc. | a411c118-ef0e-4c42-9924-4a06ec690e94 | 2021-01-14 | Adverse reactions | SODIUM CHLORIDE |
| SODIUM CHLORIDE | SODIUM CHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | ac0fd44a-3f39-8d7e-e053-2995a90afeec | 2020-08-04 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Sodium Chloride | SODIUM CHLORIDE | Baxter Healthcare Corporation | fbc01464-8885-4075-af41-911ffec5ae92 | 2020-01-27 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| WinCo Foods Saline Nasal Relief | SODIUM CHLORIDE | WinCo Foods, LLC | 1280fee4-e763-49ba-8722-8cdb8157f1a4 | 2018-08-02 | Warnings | SODIUM CHLORIDE |
| Sodium Chloride | SODIUM CHLORIDE | Baxter Healthcare Corporation | 05dee566-7b82-4216-8a6b-765d2b4d9dc7 | 2018-07-17 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Sodium Chloride | SODIUM CHLORIDE | Baxter Healthcare Corporation | 181705c7-40e4-4d7d-b9ea-ada99380e7a9 | 2018-05-23 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Sodium Chloride | SODIUM CHLORIDE | Baxter Healthcare Corporation | 7c72520e-de3c-493d-8aea-11933376d968 | 2018-04-02 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Sodium Chloride | SODIUM CHLORIDE | Baxter Healthcare Company | 886f889b-f3cf-4197-b307-6cfa88c89436 | 2017-05-04 | SODIUM CHLORIDE | |
| Sodium Chloride | SODIUM CHLORIDE | Baxter Healthcare Corporation | 2a96096d-43cc-49b7-af53-b53c17f41001 | 2014-07-25 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| SODIUM CHLORIDE | SODIUM CHLORIDE | Baxter Healthcare Corporation | b3b4b176-41f0-4ca8-90d4-3fba5707564a | 2014-02-21 | SODIUM CHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.