FDA — authorised 21 October 1986
- Application: NDA018892
- Marketing authorisation holder: HOSPIRA
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 SODIUM PHOSPHATE, DIBASIC, ANHYDROUS in United States
FDA authorised SODIUM PHOSPHATE, DIBASIC, ANHYDROUS on 21 October 1986 · 140 US adverse-event reports
Marketing authorisations
FDA — authorised 30 December 2011
- Application: ANDA079247
- Marketing authorisation holder: NOVEL LABS INC
- Local brand name: MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 March 2022
- Application: ANDA209997
- Marketing authorisation holder: FRESENIUS KABI USA
- Status: approved
FDA — authorised 21 June 2024
- Application: ANDA218314
- Marketing authorisation holder: AM REGENT
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 140
Most-reported reactions
- Vomiting — 21 reports (15%)
- General Physical Health Deterioration — 18 reports (12.86%)
- Nausea — 16 reports (11.43%)
- Ascites — 13 reports (9.29%)
- Constipation — 13 reports (9.29%)
- Infection — 13 reports (9.29%)
- White Blood Cell Count Decreased — 13 reports (9.29%)
- Neutrophil Count Decreased — 12 reports (8.57%)
- Overdose — 11 reports (7.86%)
- Underdose — 10 reports (7.14%)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is SODIUM PHOSPHATE, DIBASIC, ANHYDROUS approved in United States?
Yes. FDA authorised it on 21 October 1986; FDA authorised it on 30 December 2011; FDA authorised it on 30 March 2022.
Who is the marketing authorisation holder for SODIUM PHOSPHATE, DIBASIC, ANHYDROUS in United States?
HOSPIRA holds the US marketing authorisation.