FDA — authorised 24 December 1991
- Application: NDA019583
- Marketing authorisation holder: SMITHKLINE BEECHAM
- Local brand name: RELAFEN
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Relafen in United States
FDA authorised Relafen on 24 December 1991
Marketing authorisations
FDA — authorised 24 December 1991
- Status: approved
FDA — authorised 26 May 2000
- Application: ANDA075189
- Marketing authorisation holder: IMPAX LABS INC
- Local brand name: NABUMETONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 June 2000
- Application: ANDA075179
- Marketing authorisation holder: COPLEY PHARM
- Local brand name: NABUMETONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 February 2002
- Application: ANDA075280
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: NABUMETONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 February 2002
- Application: ANDA075590
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: NABUMETONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 March 2008
- Application: ANDA078671
- Marketing authorisation holder: INVAGEN PHARMS
- Local brand name: NABUMETONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 September 2008
- Application: ANDA078420
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: NABUMETONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 July 2010
- Application: ANDA090516
- Marketing authorisation holder: AUROBINDO PHARMA USA
- Local brand name: NABUMETONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 January 2011
- Application: ANDA090445
- Marketing authorisation holder: ANNORA PHARMA
- Local brand name: NABUMETONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 December 2011
- Application: ANDA090427
- Marketing authorisation holder: MPP PHARMA
- Local brand name: NABUMETONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 August 2019
- Application: ANDA203166
- Marketing authorisation holder: LGM PHARMA
- Local brand name: NABUMETONE
- Indication: TABLET — ORAL
- Status: approved
Relafen in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Relafen approved in United States?
Yes. FDA authorised it on 24 December 1991; FDA authorised it on 24 December 1991; FDA authorised it on 26 May 2000.
Who is the marketing authorisation holder for Relafen in United States?
SMITHKLINE BEECHAM holds the US marketing authorisation.