FDA — authorised 25 January 2012
- Application: ANDA090145
- Marketing authorisation holder: NOVEL LABS INC
- Status: approved
🇺🇸 SODIUM SULFATE in United States
FDA authorised SODIUM SULFATE on 25 January 2012 · 761 US adverse-event reports
Marketing authorisations
FDA — authorised 23 February 2017
- Application: ANDA202511
- Marketing authorisation holder: NOVEL LABS INC
- Local brand name: SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 5 June 2020
- Application: NDA019011
- Marketing authorisation holder: AZURITY
- Indication: Labeling
- Status: approved
FDA — authorised 5 August 2020
- Application: NDA022372
- Marketing authorisation holder: AZURITY
- Indication: Efficacy
- Status: approved
FDA — authorised 22 November 2023
- Application: ANDA215469
- Marketing authorisation holder: STRIDES PHARMA INTL
- Status: approved
FDA — authorised 29 December 2023
- Application: ANDA213924
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 19 March 2024
- Application: ANDA206431
- Marketing authorisation holder: TARO
- Local brand name: SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 24 June 2024
- Application: ANDA204135
- Marketing authorisation holder: BIONPHARMA
- Local brand name: SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 18 October 2024
- Application: ANDA212903
- Marketing authorisation holder: ANNORA PHARMA
- Local brand name: SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE
- Indication: SOLUTION — ORAL
- 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: 761
Most-reported reactions
- Nausea — 130 reports (17.08%)
- Vomiting — 128 reports (16.82%)
- Drug Ineffective — 108 reports (14.19%)
- Headache — 67 reports (8.8%)
- Off Label Use — 65 reports (8.54%)
- Abdominal Pain — 61 reports (8.02%)
- Macular Degeneration — 59 reports (7.75%)
- Constipation — 53 reports (6.96%)
- No Adverse Event — 48 reports (6.31%)
- Pain — 42 reports (5.52%)
SODIUM SULFATE 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 SULFATE approved in United States?
Yes. FDA authorised it on 25 January 2012; FDA authorised it on 23 February 2017; FDA authorised it on 5 June 2020.
Who is the marketing authorisation holder for SODIUM SULFATE in United States?
NOVEL LABS INC holds the US marketing authorisation.