Sodium chloride
As of the edition of 20 October 2026, Sodium chloride is a small molecule: marketed, first approved in 1951 (CA).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2018
- Kind
- Small molecule
- Brand name
- Sodium Chloride 0.9% In Plastic Container
- First approved
- 31 December 1951 (CA)
- Approvals on record
- 577 in 3 regions
- Holder of the most recent approval
- Clinigen; 34 holders in all
- Registered trials
- 356, 37 stopped early
- Disease areas
- Infections; Lungs and airways; Nervous system; Urinary and reproductive; Pregnancy and women's health; Digestive system
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 102 | 54 | 17 | 7 |
| Phase 1 | 56 | 37 | 7 | 7 |
| Phase 2 | 56 | 35 | 13 | 4 |
| Phase 3 | 57 | 31 | 10 | 9 |
| Phase 4 | 85 | 49 | 14 | 10 |
| All trials | 356 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Applicant, Acquired holder and Lead sponsor of trials | 1951 to now |
| Baxter Healthcare | Later holder and Lead sponsor of trials | 1957 to now |
| Alk-Abello | Later holder | 1963 to now |
| Alcon | Later holder | 1980 to now |
| Astellas | Later holder | 1987 to now |
| Blairex | Later holder | 1992 to now |
| Johnson & Johnson | Later holder | 1994 to now |
| Abbott | Acquired holder and Later holder | 2003 to now |
| Abraxis Pharmaceutical | Acquired holder | 2006 to now |
| Byk-Mallinckrodt CIL | Later holder | 2006 to now |
| Bayer | Later holder and Lead sponsor of trials | 2011 to now |
| Medefil | Later holder | 2012 to now |
| Liebel-Flarsheim | Acquired holder | 2015 to now |
| GSK | Later holder | 2015 to now |
| EA Pharma | Applicant | 2018 to now |
| Greer | Later holder | 2024 to now |
| Otsuka | Acquired holder | 2025 to now |
| Clinigen | Later holder | 2025 to now |
| B. Braun Medical | Later holder |