FDA — authorised 9 January 1986
- Status: approved
🇺🇸 Orudis in United States
FDA authorised Orudis on 9 January 1986
Marketing authorisations
FDA — authorised 9 January 1986
- Application: NDA018754
- Marketing authorisation holder: WYETH AYERST
- Local brand name: ORUDIS
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 December 1992
- Application: ANDA073515
- Marketing authorisation holder: TEVA
- Local brand name: KETOPROFEN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 December 1992
- Application: ANDA073516
- Marketing authorisation holder: TEVA
- Local brand name: KETOPROFEN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 December 1992
- Application: ANDA073517
- Marketing authorisation holder: TEVA
- Local brand name: KETOPROFEN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 29 January 1993
- Application: ANDA074014
- Marketing authorisation holder: MISEMER
- Local brand name: KETOPROFEN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 24 September 1993
- Application: NDA019816
- Marketing authorisation holder: WYETH PHARMS INC
- Local brand name: ORUVAIL
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 6 October 1995
- Application: NDA020499
- Marketing authorisation holder: BAYER
- Local brand name: ACTRON
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 October 1995
- Application: NDA020429
- Marketing authorisation holder: WYETH CONS
- Local brand name: ORUDIS KT
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 December 1995
- Application: ANDA074024
- Marketing authorisation holder: RISING
- Local brand name: KETOPROFEN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 31 December 1996
- Application: ANDA074035
- Marketing authorisation holder: RISING
- Local brand name: KETOPROFEN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 10 December 1997
- Application: ANDA074879
- Marketing authorisation holder: ALKERMES GAINESVILLE
- Local brand name: KETOPROFEN
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 24 March 1999
- Application: ANDA075270
- Marketing authorisation holder: ACTAVIS LABS FL INC
- Local brand name: KETOPROFEN
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 7 February 2002
- Application: ANDA075364
- Marketing authorisation holder: PERRIGO
- Local brand name: KETOPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 February 2002
- Application: ANDA075679
- Marketing authorisation holder: MYLAN
- Local brand name: KETOPROFEN
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 25 November 2009
- Application: NDA022470
- Marketing authorisation holder: NOVARTIS
- Local brand name: NEXCEDE
- Indication: FILM — ORAL
- Status: approved
Orudis 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 Orudis approved in United States?
Yes. FDA authorised it on 9 January 1986; FDA authorised it on 9 January 1986; FDA authorised it on 22 December 1992.
Who is the marketing authorisation holder for Orudis in United States?
Marketing authorisation holder not available in our data.