FDA — authorised 28 February 1986
- Application: ANDA070431
- Marketing authorisation holder: PAR PHARM
- Local brand name: VALPROIC ACID
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 VALPROIC ACID in United States
FDA authorised VALPROIC ACID on 28 February 1986 · 19,323 US adverse-event reports
Marketing authorisations
FDA — authorised 1 July 1986
- Application: ANDA070868
- Marketing authorisation holder: PHARMOBEDIENT CNSLTG
- Local brand name: VALPROIC ACID
- Indication: SYRUP — 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 2 July 1987
- Application: ANDA070195
- Marketing authorisation holder: SCHERER RP
- Local brand name: VALPROIC ACID
- Indication: CAPSULE — 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 13 January 1995
- Application: ANDA074060
- Marketing authorisation holder: HIKMA
- Local brand name: VALPROIC ACID
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 15 December 2000
- Application: ANDA075379
- Marketing authorisation holder: PHARM ASSOC
- Local brand name: VALPROIC ACID
- Indication: SYRUP — 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 29 July 2005
- Application: ANDA077105
- Marketing authorisation holder: PAI HOLDINGS
- Local brand name: VALPROIC ACID
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 13 October 2006
- Application: ANDA077960
- Marketing authorisation holder: LANNETT CO INC
- Local brand name: VALPROIC ACID
- Indication: SYRUP — ORAL
- 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 22 February 2013
- Application: ANDA091037
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: VALPROIC ACID
- Indication: CAPSULE — 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
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: 19,323
Most-reported reactions
- Drug Ineffective — 3,725 reports (19.28%)
- Drug Interaction — 3,558 reports (18.41%)
- Off Label Use — 2,103 reports (10.88%)
- Toxicity To Various Agents — 2,002 reports (10.36%)
- Seizure — 1,937 reports (10.02%)
- Completed Suicide — 1,364 reports (7.06%)
- Somnolence — 1,297 reports (6.71%)
- Depression — 1,222 reports (6.32%)
- Condition Aggravated — 1,129 reports (5.84%)
- Overdose — 986 reports (5.1%)
VALPROIC ACID 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 VALPROIC ACID approved in United States?
Yes. FDA authorised it on 28 February 1986; FDA authorised it on 1 July 1986; FDA authorised it on 11 June 1987.
Who is the marketing authorisation holder for VALPROIC ACID in United States?
PAR PHARM holds the US marketing authorisation.