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SODIUM CHLORIDE | INJECTABLE;INJECTION | 234MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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IN PLASTIC CONTAINER | SODIUM CHLORIDE | 234MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1987-04-22 |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CHLORIDE 23.4% IN PLASTIC CONTAINER | 234MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1987-04-22 | c2088c7a36db… | |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CHLORIDE 23.4% IN PLASTIC CONTAINER | 234MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1987-04-22 | 84e616aacf4f… | |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CHLORIDE 23.4% IN PLASTIC CONTAINER | 234MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1987-04-22 | caaa826d4ba7… | |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CHLORIDE 23.4% IN PLASTIC CONTAINER | 234MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD | 1987-04-22 | 011fe1cb6892… | |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 |
|---|---|---|---|---|---|---|
| Muro 128 | SODIUM CHLORIDE | Bausch & Lomb Incorporated | 93fafa27-5031-4d95-b4b8-5574b7204ae2 | 2024-09-25 | Warnings | SODIUM CHLORIDE |
| Muro 128 | SODIUM CHLORIDE | Bausch & Lomb Incorporated | 454f337e-d897-46de-ab05-1c543a33061c | 2024-09-25 | Warnings | SODIUM CHLORIDE |
| Sodium Chloride | SODIUM CHLORIDE | Baxter Healthcare Corporation | f55bd888-5e01-474d-871b-24654c070178 | 2024-07-24 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Sodium chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | 83994d0c-8484-4505-abb5-8a384ed12288 | 2024-07-22 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| sodium chloride | SODIUM CHLORIDE | Becton Dickinson and Company | 8df7dcf6-8714-6caf-e053-2995a90ab8cc | 2024-07-15 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Sodium Chloride | SODIUM CHLORIDE | CODAN US CORPORATION | aa06e286-75c6-4d7a-959f-6008d38aa6e5 | 2024-06-24 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Sodium chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | 239a5af1-7498-480f-862c-ab7c3d89d183 | 2024-05-21 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Sodium chloride | SODIUM CHLORIDE | Becton Dickinson and Company | ebc8b008-a8b3-4c41-89e4-b413f7aab89f | 2024-05-21 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Sodium Chloride | SODIUM CHLORIDE | B. Braun Medical Inc. | 47a0313f-36df-4fa6-a828-c9e1946ba9b0 | 2024-05-08 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Sodium Chloride | SODIUM CHLORIDE | B. Braun Medical Inc. | 7f22c06b-6b4d-4b49-a4b2-d2169f2bd653 | 2024-05-07 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Sodium Chloride | SODIUM CHLORIDE | B. Braun Medical Inc. | f2475fa3-ab1d-4b81-8127-b58cd0790a54 | 2024-05-06 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Sodium chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | c1e52670-c85e-4f19-a2e9-bf9abd7c3727 | 2024-04-23 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Sodium Chloride | SODIUM CHLORIDE | Hikma Pharmaceuticals USA Inc. | e5ee8caa-b6ca-45ba-98fb-8305e6282141 | 2024-04-10 | Adverse reactions | SODIUM CHLORIDE |
| CVS Health Sterile Saline Mist | SODIUM CHLORIDE | CVS Pharmacy | 14931004-1efb-e331-e063-6294a90ad66e | 2024-03-26 | Warnings | SODIUM CHLORIDE |
| Aqua marina | SODIUM CHLORIDE | Boiron | 14945760-30b5-27d3-e063-6394a90a8a32 | 2024-03-26 | SODIUM CHLORIDE | |
| Natrum Muriaticum | SODIUM CHLORIDE | SEVENE USA | 11008014-fff6-4d5a-8c5c-a20443d7cc23 | 2024-01-30 | Warnings | SODIUM CHLORIDE |
| Sodium Chloride | SODIUM CHLORIDE | Spectra Medical Deviecs, LLC | 7e316d21-d6ad-4976-bd90-268fd7e51361 | 2024-01-12 | Adverse reactions | SODIUM CHLORIDE |
| Sodium chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | 037ac04d-f8f3-4bb8-993a-ac8f7683ff83 | 2024-01-04 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Altachlore Sodium Chloride Hypertonicity | SODIUM CHLORIDE | Altaire Pharmaceuticals Inc. | dc0d94d8-4475-4956-8ded-bdb9496074e4 | 2023-12-09 | Warnings | SODIUM CHLORIDE |
| Natrum muriaticum | SODIUM CHLORIDE | Boiron | 8646d7ea-cf5e-607d-e053-2a91aa0aeca1 | 2023-11-14 | SODIUM CHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.