FDA — authorised 28 February 1978
- Application: NDA018082
- Marketing authorisation holder: ABBVIE
- Local brand name: DEPAKENE
- Indication: SYRUP — ORAL
- Status: approved
🇺🇸 Valproate in United States
FDA authorised Valproate on 28 February 1978 · 17,043 US adverse-event reports
Marketing authorisations
FDA — authorised 28 February 1978
- Application: NDA018081
- Marketing authorisation holder: ABBVIE
- Local brand name: DEPAKENE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 10 March 1983
- Application: NDA018723
- Marketing authorisation holder: ABBVIE
- Local brand name: DEPAKOTE
- Indication: TABLET, DELAYED RELEASE — ORAL
- Status: approved
FDA — authorised 28 February 1986
- Application: ANDA070431
- Marketing authorisation holder: PAR PHARM
- Local brand name: VALPROIC ACID
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 11 June 1987
- Application: ANDA070631
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: VALPROIC ACID
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 12 September 1989
- Application: NDA019680
- Marketing authorisation holder: ABBVIE
- Local brand name: DEPAKOTE
- Indication: CAPSULE, DELAYED REL PELLETS — ORAL
- Status: approved
FDA — authorised 29 June 1993
- Application: ANDA073484
- Marketing authorisation holder: BIONPHARMA
- Local brand name: VALPROIC ACID
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 December 2000
- Application: ANDA075782
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: VALPROIC ACID
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 14 November 2002
- Application: ANDA076295
- Marketing authorisation holder: SAGENT
- Indication: Labeling
- Status: approved
FDA — authorised 26 June 2003
- Application: ANDA076539
- Marketing authorisation holder: FRESENIUS KABI USA
- Status: approved
FDA — authorised 29 July 2005
- Application: ANDA077105
- Marketing authorisation holder: PAI HOLDINGS
- Local brand name: VALPROIC ACID
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 17 February 2010
- Application: ANDA078523
- Marketing authorisation holder: HIKMA FARMACEUTICA
- Indication: Labeling
- Status: approved
FDA — authorised 28 May 2010
- Application: ANDA090517
- Marketing authorisation holder: QUAGEN
- Local brand name: VALPROIC ACID
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 5 August 2019
- Application: ANDA207611
- Marketing authorisation holder: HIBROW HLTHCARE
- Local brand name: VALPROIC ACID
- Indication: CAPSULE — 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: 17,043
Most-reported reactions
- Drug Ineffective — 3,171 reports (18.61%)
- Drug Interaction — 2,161 reports (12.68%)
- Off Label Use — 2,116 reports (12.42%)
- Seizure — 1,716 reports (10.07%)
- Somnolence — 1,562 reports (9.17%)
- Foetal Exposure During Pregnancy — 1,444 reports (8.47%)
- Epilepsy — 1,366 reports (8.02%)
- Toxicity To Various Agents — 1,314 reports (7.71%)
- Pyrexia — 1,141 reports (6.69%)
- Condition Aggravated — 1,052 reports (6.17%)
Valproate in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Valproate approved in United States?
Yes. FDA authorised it on 28 February 1978; FDA authorised it on 28 February 1978; FDA authorised it on 10 March 1983.
Who is the marketing authorisation holder for Valproate in United States?
ABBVIE holds the US marketing authorisation.