FDA — authorised 30 October 1989
- Application: NDA019937
- Marketing authorisation holder: ASTELLAS
- Local brand name: ADENOCARD
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Adenocard in United States
FDA authorised Adenocard on 30 October 1989
Marketing authorisations
FDA — authorised 16 June 2004
- Application: ANDA076500
- Marketing authorisation holder: HIKMA
- Local brand name: ADENOSINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 June 2004
- Application: ANDA076501
- Marketing authorisation holder: HIKMA
- Local brand name: ADENOSINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 June 2004
- Application: ANDA076564
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: ADENOSINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 April 2005
- Application: ANDA077133
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: ADENOSINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 14 January 2008
- Application: ANDA077283
- Marketing authorisation holder: GLAND PHARMA LTD
- Indication: Labeling
- Status: approved
FDA — authorised 31 July 2008
- Application: ANDA078676
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: ADENOSINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 October 2008
- Application: ANDA078076
- Marketing authorisation holder: RISING
- Local brand name: ADENOSINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 July 2009
- Application: ANDA090220
- Marketing authorisation holder: WOCKHARDT
- Local brand name: ADENOSINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 4 February 2010
- Application: ANDA078686
- Marketing authorisation holder: MYLAN LABS LTD
- Indication: Labeling
- Status: approved
FDA — authorised 29 August 2013
- Application: ANDA077425
- Marketing authorisation holder: MEITHEAL
- Local brand name: ADENOSINE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 21 March 2014
- Application: ANDA078640
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: ADENOSINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 March 2014
- Application: ANDA090212
- Marketing authorisation holder: MYLAN ASI
- Local brand name: ADENOSINE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 15 September 2014
- Application: ANDA202313
- Marketing authorisation holder: AVET LIFESCIENCES
- Status: approved
FDA — authorised 2 October 2014
- Application: ANDA090450
- Marketing authorisation holder: RISING
- Local brand name: ADENOSINE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 2 November 2017
- Application: ANDA205331
- Marketing authorisation holder: EUGIA PHARMA
- Status: approved
FDA — authorised 27 November 2017
- Application: ANDA077897
- Marketing authorisation holder: FRESENIUS KABI USA
- Status: approved
FDA — authorised 16 February 2018
- Application: ANDA206778
- Marketing authorisation holder: GLAND
- Local brand name: ADENOSINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 April 2018
- Application: ANDA205568
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: ADENOSINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA079147
- Marketing authorisation holder: WOCKHARDT
- Local brand name: ADENOSINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA078618
- Marketing authorisation holder: BEDFORD LABS
- Local brand name: ADENOSINE
- Indication: INJECTABLE — INJECTION
- Status: approved
Adenocard 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 Adenocard approved in United States?
Yes. FDA authorised it on 30 October 1989; FDA authorised it on 16 June 2004; FDA authorised it on 16 June 2004.
Who is the marketing authorisation holder for Adenocard in United States?
ASTELLAS holds the US marketing authorisation.