FDA — authorised 7 August 1990
- Application: NDA019813
- Marketing authorisation holder: JANSSEN PHARMS
- Local brand name: DURAGESIC-50
- Indication: FILM, EXTENDED RELEASE — TRANSDERMAL
- Status: approved
🇺🇸 TIVA in United States
FDA authorised TIVA on 7 August 1990
Marketing authorisations
FDA — authorised 28 January 2005
- Application: ANDA076258
- Marketing authorisation holder: MYLAN TECHNOLOGIES
- Local brand name: FENTANYL-87
- Indication: FILM, EXTENDED RELEASE — TRANSDERMAL
- Status: approved
FDA — authorised 19 April 2005
- Application: ANDA074848
- Marketing authorisation holder: HIKMA
- Local brand name: PROPOFOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 4 August 2006
- Application: ANDA077051
- Marketing authorisation holder: LAVIPHARM LABS
- Local brand name: FENTANYL-50
- Indication: FILM, EXTENDED RELEASE — TRANSDERMAL
- Status: approved
FDA — authorised 20 August 2007
- Application: ANDA077062
- Marketing authorisation holder: MAYNE PHARMA
- Local brand name: FENTANYL-50
- Indication: FILM, EXTENDED RELEASE — TRANSDERMAL
- Status: approved
FDA — authorised 20 October 2008
- Application: ANDA077449
- Marketing authorisation holder: DIFGEN PHARMS
- Local brand name: FENTANYL-12
- Indication: FILM, EXTENDED RELEASE — TRANSDERMAL
- Status: approved
FDA — authorised 16 October 2009
- Application: ANDA077775
- Marketing authorisation holder: NOVEN
- Local brand name: FENTANYL-100
- Indication: FILM, EXTENDED RELEASE — TRANSDERMAL
- Status: approved
FDA — authorised 9 February 2011
- Application: ANDA077154
- Marketing authorisation holder: SPECGX LLC
- Local brand name: FENTANYL-12
- Indication: FILM, EXTENDED RELEASE — TRANSDERMAL
- Status: approved
FDA — authorised 4 November 2016
- Application: ANDA202097
- Marketing authorisation holder: KINDEVA
- Local brand name: FENTANYL-25
- Indication: FILM, EXTENDED RELEASE — TRANSDERMAL
- Status: approved
FDA — authorised 15 November 2018
- Application: ANDA205067
- Marketing authorisation holder: DR REDDYS
- Local brand name: PROPOFOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 September 2020
- Application: ANDA205576
- Marketing authorisation holder: INNOPHARMA
- Local brand name: PROPOFOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 12 October 2021
- Application: ANDA206408
- Marketing authorisation holder: AVET LIFESCIENCES
- Local brand name: PROPOFOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 January 2023
- Application: ANDA209655
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: FENTANYL-12
- Indication: FILM, EXTENDED RELEASE — TRANSDERMAL
- Status: approved
FDA — authorised 20 June 2024
- Application: ANDA217013
- Marketing authorisation holder: ASPIRO
- Local brand name: PROPOFOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA202577
- Marketing authorisation holder: MYLAN PHARMS INC
- Local brand name: FENTANYL
- Indication: TABLET — BUCCAL
- Status: approved
FDA
- Status: approved
TIVA in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is TIVA approved in United States?
Yes. FDA authorised it on 7 August 1990; FDA authorised it on 28 January 2005; FDA authorised it on 19 April 2005.
Who is the marketing authorisation holder for TIVA in United States?
JANSSEN PHARMS holds the US marketing authorisation.