FDA — authorised 10 February 1998
- Marketing authorisation holder: GLAXOSMITHKLINE LLC
- Status: approved
🇺🇸 Amerge in United States
FDA authorised Amerge on 10 February 1998
Marketing authorisations
FDA — authorised 7 July 2010
- Application: ANDA090288
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: NARATRIPTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 July 2010
- Application: ANDA078751
- Marketing authorisation holder: ANI PHARMS
- Local brand name: NARATRIPTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 July 2010
- Application: ANDA090381
- Marketing authorisation holder: HIKMA
- Local brand name: NARATRIPTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 July 2010
- Application: ANDA091326
- Marketing authorisation holder: PADAGIS US
- Local brand name: NARATRIPTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 February 2011
- Application: ANDA091552
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: NARATRIPTAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 April 2012
- Application: ANDA091441
- Marketing authorisation holder: ORBION PHARMS
- Local brand name: NARATRIPTAN
- Indication: TABLET — ORAL
- Status: approved
Amerge 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 Amerge approved in United States?
Yes. FDA authorised it on 10 February 1998; FDA authorised it on 7 July 2010; FDA authorised it on 7 July 2010.
Who is the marketing authorisation holder for Amerge in United States?
GLAXOSMITHKLINE LLC holds the US marketing authorisation.