FDA — authorised 26 February 1982
- Application: NDA018660
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: TRAVAMULSION 10%
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 SOYBEAN OIL in United States
FDA authorised SOYBEAN OIL on 26 February 1982 · 1,152 US adverse-event reports
Marketing authorisations
FDA — authorised 29 June 1983
- Application: NDA018465
- Marketing authorisation holder: ALPHA THERA
- Local brand name: SOYACAL 10%
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 19 August 1985
- Application: NDA018758
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: TRAVAMULSION 20%
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 May 1993
- Application: NDA019531
- Marketing authorisation holder: B BRAUN
- Local brand name: NUTRILIPID 10%
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- 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: 1,152
Most-reported reactions
- Pyrexia — 199 reports (17.27%)
- Chills — 177 reports (15.36%)
- Nausea — 123 reports (10.68%)
- General Physical Health Deterioration — 113 reports (9.81%)
- Diarrhoea — 103 reports (8.94%)
- Dyspnoea — 99 reports (8.59%)
- Vomiting — 93 reports (8.07%)
- Abdominal Pain — 91 reports (7.9%)
- Off Label Use — 85 reports (7.38%)
- Death — 69 reports (5.99%)
SOYBEAN OIL 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 SOYBEAN OIL approved in United States?
Yes. FDA authorised it on 26 February 1982; FDA authorised it on 29 June 1983; FDA authorised it on 19 August 1985.
Who is the marketing authorisation holder for SOYBEAN OIL in United States?
BAXTER HLTHCARE holds the US marketing authorisation.