FDA — authorised 24 December 1998
- Application: NDA020717
- Marketing authorisation holder: NUVO PHARMS
- Local brand name: PROVIGIL
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Provigil in United States
FDA authorised Provigil on 24 December 1998
Marketing authorisations
FDA — authorised 16 July 2012
- Application: ANDA076594
- Marketing authorisation holder: NATCO PHARMA
- Local brand name: MODAFINIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 September 2012
- Application: ANDA078963
- Marketing authorisation holder: ORBION PHARMS
- Local brand name: MODAFINIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 26 September 2012
- Application: ANDA090543
- Marketing authorisation holder: HIKMA PHARMS
- Local brand name: MODAFINIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 September 2012
- Application: ANDA202566
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: MODAFINIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 October 2012
- Application: ANDA202700
- Marketing authorisation holder: ALEMBIC
- Local brand name: MODAFINIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 February 2014
- Application: ANDA077667
- Marketing authorisation holder: APOTEX
- Local brand name: MODAFINIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 August 2017
- Application: ANDA207196
- Marketing authorisation holder: APPCO
- Local brand name: MODAFINIL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 September 2017
- Application: ANDA209966
- Marketing authorisation holder: CADILA
- Local brand name: MODAFINIL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA076596
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: MODAFINIL
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA076597
- Marketing authorisation holder: BARR
- Local brand name: MODAFINIL
- Indication: Tablet — Oral
- Status: approved
FDA
- Application: ANDA076935
- Marketing authorisation holder: SANDOZ
- Local brand name: MODAFINIL
- Indication: TABLET — ORAL
- Status: approved
Provigil 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 Provigil approved in United States?
Yes. FDA authorised it on 24 December 1998; FDA authorised it on 16 July 2012; FDA authorised it on 26 September 2012.
Who is the marketing authorisation holder for Provigil in United States?
NUVO PHARMS holds the US marketing authorisation.