FDA — authorised 4 March 1964
- Application: NDA013416
- Marketing authorisation holder: BAUSCH
- Local brand name: NORGESIC
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Norgesic in United States
FDA authorised Norgesic on 4 March 1964
Marketing authorisations
FDA — authorised 5 November 1980
- Application: ANDA086562
- Marketing authorisation holder: ORGANON USA INC
- Local brand name: WIGRAINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 September 2004
- Application: ANDA040510
- Marketing authorisation holder: HIKMA INTL PHARMS
- Local brand name: ERGOTAMINE TARTRATE AND CAFFEINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 September 2005
- Application: ANDA040590
- Marketing authorisation holder: MIKART
- Local brand name: ERGOTAMINE TARTRATE AND CAFFEINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 September 2006
- Application: ANDA077233
- Marketing authorisation holder: EXELA PHARMA SCIENCE
- Status: approved
FDA — authorised 13 June 2007
- Application: ANDA078149
- Marketing authorisation holder: MPP PHARMA
- Status: approved
FDA — authorised 18 October 2013
- Application: ANDA089007
- Marketing authorisation holder: DR REDDYS LABS SA
- Indication: Labeling
- Status: approved
FDA — authorised 15 April 2016
- Application: ANDA200243
- Marketing authorisation holder: LANNETT CO INC
- Indication: Labeling
- Status: approved
FDA — authorised 8 April 2020
- Application: ANDA213321
- Marketing authorisation holder: GRANULES
- Status: approved
Norgesic in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Norgesic approved in United States?
Yes. FDA authorised it on 4 March 1964; FDA authorised it on 5 November 1980; FDA authorised it on 17 September 2004.
Who is the marketing authorisation holder for Norgesic in United States?
BAUSCH holds the US marketing authorisation.