FDA — authorised 2 November 1960
- Marketing authorisation holder: PARKE DAVIS
- Status: approved
🇺🇸 Zarontin in United States
FDA authorised Zarontin on 2 November 1960
Marketing authorisations
FDA — authorised 2 November 1960
- Application: NDA012380
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: ZARONTIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 13 February 1974
- Application: ANDA080258
- Marketing authorisation holder: PARKE-DAVIS
- Local brand name: ZARONTIN
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 30 July 1993
- Application: ANDA081306
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: ETHOSUXIMIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 22 November 2000
- Application: ANDA040253
- Marketing authorisation holder: PHARM ASSOC
- Local brand name: ETHOSUXIMIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 28 October 2002
- Application: ANDA040430
- Marketing authorisation holder: BIONPHARMA
- Local brand name: ETHOSUXIMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 December 2003
- Application: ANDA040506
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: ETHOSUXIMIDE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 28 May 2008
- Application: ANDA040686
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: ETHOSUXIMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 25 September 2012
- Application: ANDA200892
- Marketing authorisation holder: HERITAGE PHARMS INC
- Local brand name: ETHOSUXIMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 16 March 2020
- Application: ANDA210654
- Marketing authorisation holder: PURACAP PHARM LLC
- Local brand name: ETHOSUXIMIDE
- Indication: CAPSULE — ORAL
- Status: approved
Zarontin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Zarontin approved in United States?
Yes. FDA authorised it on 2 November 1960; FDA authorised it on 2 November 1960; FDA authorised it on 13 February 1974.
Who is the marketing authorisation holder for Zarontin in United States?
PARKE DAVIS holds the US marketing authorisation.