FDA — authorised 30 December 1996
- Application: NDA020593
- Marketing authorisation holder: ABBVIE
- Local brand name: DEPACON
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 VALPROATE SODIUM in United States
FDA authorised VALPROATE SODIUM on 30 December 1996 · 9,764 US adverse-event reports
Marketing authorisations
FDA — authorised 14 November 2002
- Application: ANDA076295
- Marketing authorisation holder: SAGENT
- Local brand name: VALPROATE SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 June 2003
- Application: ANDA076539
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: VALPROATE SODIUM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 February 2010
- Application: ANDA078523
- Marketing authorisation holder: HIKMA FARMACEUTICA
- Local brand name: VALPROATE SODIUM
- 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: 9,764
Most-reported reactions
- Drug Ineffective — 1,448 reports (14.83%)
- Drug Interaction — 1,252 reports (12.82%)
- Off Label Use — 1,122 reports (11.49%)
- Foetal Exposure During Pregnancy — 1,055 reports (10.8%)
- Somnolence — 1,008 reports (10.32%)
- Epilepsy — 868 reports (8.89%)
- Seizure — 807 reports (8.27%)
- Toxicity To Various Agents — 784 reports (8.03%)
- Pyrexia — 767 reports (7.86%)
- Convulsion — 653 reports (6.69%)
VALPROATE SODIUM 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 VALPROATE SODIUM approved in United States?
Yes. FDA authorised it on 30 December 1996; FDA authorised it on 14 November 2002; FDA authorised it on 26 June 2003.
Who is the marketing authorisation holder for VALPROATE SODIUM in United States?
ABBVIE holds the US marketing authorisation.