Application 217535
- Type
- ANDA
- Sponsor
- NEXUS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SODIUM CHLORIDE 0.9% | SODIUM CHLORIDE | SOLUTION;INJECTION | 90MG/10ML (9MG/ML) | No | No |
| 002 | SODIUM CHLORIDE 0.9% | SODIUM CHLORIDE | SOLUTION;INJECTION | 180MG/20ML (9MG/ML) | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A217535-001 | SODIUM CHLORIDE 0.9% | SODIUM CHLORIDE | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | AP | 2023-08-23 | |
| A217535-002 | SODIUM CHLORIDE 0.9% | SODIUM CHLORIDE | 180MG/20ML (9MG/ML) | SOLUTION / INJECTION | AP | 2023-08-23 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A217535-001 | AP |
| A217535-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A217535-001 | SODIUM CHLORIDE 0.9% | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | AP | 2023-08-23 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A217535-002 | SODIUM CHLORIDE 0.9% | 180MG/20ML (9MG/ML) | SOLUTION / INJECTION | AP | 2023-08-23 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A217535-001 | SODIUM CHLORIDE 0.9% | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | AP | 2023-08-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A217535-002 | SODIUM CHLORIDE 0.9% | 180MG/20ML (9MG/ML) | SOLUTION / INJECTION | AP | 2023-08-23 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217535-001 | SODIUM CHLORIDE 0.9% | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | AP | 2023-08-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217535-002 | SODIUM CHLORIDE 0.9% | 180MG/20ML (9MG/ML) | SOLUTION / INJECTION | AP | 2023-08-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217535-001 | SODIUM CHLORIDE 0.9% | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | AP | 2023-08-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217535-002 | SODIUM CHLORIDE 0.9% | 180MG/20ML (9MG/ML) | SOLUTION / INJECTION | AP | 2023-08-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217535-001 | SODIUM CHLORIDE 0.9% | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | AP | 2023-08-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217535-002 | SODIUM CHLORIDE 0.9% | 180MG/20ML (9MG/ML) | SOLUTION / INJECTION | AP | 2023-08-23 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217535-001 | SODIUM CHLORIDE 0.9% | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | AP | 2023-08-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217535-002 | SODIUM CHLORIDE 0.9% | 180MG/20ML (9MG/ML) | SOLUTION / INJECTION | AP | 2023-08-23 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217535-001 | SODIUM CHLORIDE 0.9% | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | AP | 2023-08-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217535-002 | SODIUM CHLORIDE 0.9% | 180MG/20ML (9MG/ML) | SOLUTION / INJECTION | AP | 2023-08-23 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217535-001 | SODIUM CHLORIDE 0.9% | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | AP | 2023-08-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217535-002 | SODIUM CHLORIDE 0.9% | 180MG/20ML (9MG/ML) | SOLUTION / INJECTION | AP | 2023-08-23 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217535-001 | SODIUM CHLORIDE 0.9% | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | AP | 2023-08-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217535-002 | SODIUM CHLORIDE 0.9% | 180MG/20ML (9MG/ML) | SOLUTION / INJECTION | AP | 2023-08-23 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217535-001 | SODIUM CHLORIDE 0.9% | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | AP | 2023-08-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217535-002 | SODIUM CHLORIDE 0.9% | 180MG/20ML (9MG/ML) | SOLUTION / INJECTION | AP | 2023-08-23 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217535-001 | SODIUM CHLORIDE 0.9% | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | AP | 2023-08-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217535-002 | SODIUM CHLORIDE 0.9% | 180MG/20ML (9MG/ML) | SOLUTION / INJECTION | AP | 2023-08-23 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A217535-001 | SODIUM CHLORIDE 0.9% | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | AP | 2023-08-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A217535-002 | SODIUM CHLORIDE 0.9% | 180MG/20ML (9MG/ML) | SOLUTION / INJECTION | AP | 2023-08-23 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217535-001 | SODIUM CHLORIDE 0.9% | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | AP | 2023-08-23 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217535-002 | SODIUM CHLORIDE 0.9% | 180MG/20ML (9MG/ML) | SOLUTION / INJECTION | AP | 2023-08-23 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A217535-001 | SODIUM CHLORIDE 0.9% | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | AP | 2023-08-23 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A217535-002 | SODIUM CHLORIDE 0.9% | 180MG/20ML (9MG/ML) | SOLUTION / INJECTION | AP | 2023-08-23 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A217535-001 | SODIUM CHLORIDE 0.9% | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | AP | 2023-08-23 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A217535-002 | SODIUM CHLORIDE 0.9% | 180MG/20ML (9MG/ML) | SOLUTION / INJECTION | AP | 2023-08-23 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A217535-001 | SODIUM CHLORIDE 0.9% | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | AP | 2023-08-23 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A217535-002 | SODIUM CHLORIDE 0.9% | 180MG/20ML (9MG/ML) | SOLUTION / INJECTION | AP | 2023-08-23 | 8072bd15b7f6… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A217535-001 | SODIUM CHLORIDE 0.9% | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | AP | 2023-08-23 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A217535-002 | SODIUM CHLORIDE 0.9% | 180MG/20ML (9MG/ML) | SOLUTION / INJECTION | AP | 2023-08-23 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A217535-001 | SODIUM CHLORIDE 0.9% | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | AP | 2023-08-23 | 1c564ffb4f44… | |
| 2024-02-18 07:12 UTC | 2024-02 | A217535-002 | SODIUM CHLORIDE 0.9% | 180MG/20ML (9MG/ML) | SOLUTION / INJECTION | AP | 2023-08-23 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A217535-001 | SODIUM CHLORIDE 0.9% | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | AP | 2023-08-23 | ea1830bbd6c7… | |
| 2023-12-20 04:57 UTC | 2023-12 | A217535-002 | SODIUM CHLORIDE 0.9% | 180MG/20ML (9MG/ML) | SOLUTION / INJECTION | AP | 2023-08-23 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A217535-001 | SODIUM CHLORIDE 0.9% | 90MG/10ML (9MG/ML) | SOLUTION / INJECTION | AP | 2023-08-23 | a72a2bbeb626… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A217535-002 | SODIUM CHLORIDE 0.9% | 180MG/20ML (9MG/ML) | SOLUTION / INJECTION | AP | 2023-08-23 | a72a2bbeb626… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A217535-001 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A217535-002 | AP | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A217535-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A217535-002 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A217535-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A217535-002 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217535-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217535-002 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A217535-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A217535-002 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217535-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217535-002 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217535-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217535-002 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217535-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217535-002 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217535-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217535-002 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217535-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217535-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217535-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217535-002 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A217535-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A217535-002 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217535-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217535-002 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A217535-001 | AP | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A217535-002 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A217535-001 | AP | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A217535-002 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A217535-001 | AP | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A217535-002 | AP | 1 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A217535-001 | AP | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A217535-002 | AP | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A217535-001 | AP | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A217535-002 | AP | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A217535-001 | AP | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A217535-002 | AP | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A217535-001 | AP | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A217535-002 | AP | 1 | a72a2bbeb626… |
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 | d98bf9f7-30ec-4927-a577-cabad192cb18 | 2026-01-19 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Sodium Chloride Hypertonicity | SODIUM CHLORIDE | CVS Pharmacy | 9245d842-7f78-42d8-83ba-8eb9ec8dbc0d | 2026-01-15 | Warnings | SODIUM CHLORIDE |
| Sodium Chloride Hypertonicity | SODIUM CHLORIDE | CVS PHARMACY | d5cc6cd1-ddf8-4f5b-a021-204cdda0db94 | 2026-01-15 | Warnings | SODIUM CHLORIDE |
| Sodium chloride | SODIUM CHLORIDE | BECTON DICKINSON AND COMPANY | d39b7307-df67-4e68-acb0-2eda5dc61215 | 2026-01-07 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Normal Salt | SODIUM CHLORIDE | GRAXCELL PHARMACEUTICAL, LLC | f3f09817-8a38-4aa1-956b-69d9cf695074 | 2025-12-25 | Warnings | SODIUM CHLORIDE |
| Sodium Chloride | SODIUM CHLORIDE | ProPharma Distribution | 3f79fb8b-d0e8-db2a-e063-6394a90ac136 | 2025-12-18 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Rhinomel Manuka | SODIUM CHLORIDE | Melcare Biomedical Pty Ltd | 35a7ce7d-4a26-e3f0-e063-6294a90ad66f | 2025-12-09 | Warnings | SODIUM CHLORIDE |
| Sodium Chloride | SODIUM CHLORIDE | SOLA Pharmaceuticals, LLC | 4d0bfd28-460a-48ba-bd17-cf75e56d62f4 | 2025-12-09 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Sterile Saline Mist Meijer | SODIUM CHLORIDE | Meijer, Inc. | 445c8f4f-0519-0764-e063-6294a90a8b39 | 2025-12-01 | Warnings | SODIUM CHLORIDE |
| Sodium Chloride | SODIUM CHLORIDE | Walgreen Company | d112a344-33cc-41d3-bae6-492631ebdba7 | 2025-11-19 | Warnings | SODIUM CHLORIDE |
| Sodium chloride | SODIUM CHLORIDE | Fresenius Kabi USA, LLC | ce0c8c6f-734a-400f-9b60-a3b1e263f25f | 2025-11-18 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| SODIUM CHLORIDE | SODIUM CHLORIDE | Hospira, Inc. | af6aebad-ef03-4d19-9a40-18e5a278b812 | 2025-11-11 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| SODIUM CHLORIDE | SODIUM CHLORIDE | Henry Schein, Inc. | 2e81ffca-05c6-4fa0-8911-4b3cbfa71351 | 2025-11-07 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Sodium Chloride | SODIUM CHLORIDE | Rising Pharma Holdings, Inc. | 42870188-b1d7-4934-a6c0-310530497dac | 2025-11-07 | Warnings | SODIUM CHLORIDE |
| Sodium Chloride | SODIUM CHLORIDE | Henry Schein, Inc. | d8b8d796-bfba-42af-a859-99d776871558 | 2025-11-07 | Adverse reactions | SODIUM CHLORIDE |
| Bacteriostatic Sodium Chloride | SODIUM CHLORIDE | Henry Schein, Inc. | 31188cdf-7bc8-4d78-bfaf-c1dc9f851fd4 | 2025-11-07 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Sodium Chloride | SODIUM CHLORIDE | ICU Medical Inc. | 3cfdeee0-ff14-4341-8396-b11c2a037c60 | 2025-11-02 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Sodium Chloride | SODIUM CHLORIDE | ICU Medical Inc. | 5f372b75-d7a4-471e-8ac6-290040fc84b0 | 2025-11-02 | Warnings, Adverse reactions | SODIUM CHLORIDE |
| Family Care Saline | SODIUM CHLORIDE | United Exchange Corp. | 06737393-d4ae-3e7b-e063-6394a90ac19f | 2025-10-31 | Warnings | SODIUM CHLORIDE |
| Sodium Chloride | SODIUM CHLORIDE | ICU Medical Inc. | 009bef3c-e8ac-46be-b564-a2556adf0081 | 2025-10-31 | Warnings, Adverse reactions | SODIUM CHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 75302 | ORIG | 2023-08-28 |