FDA — authorised 21 September 2006
- Application: ANDA077233
- Marketing authorisation holder: EXELA PHARMA SCIENCE
- Local brand name: CAFFEINE CITRATE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
🇺🇸 Vivarin in United States
FDA authorised Vivarin on 21 September 2006
Marketing authorisations
FDA — authorised 20 July 2007
- Application: ANDA077997
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: CAFFEINE CITRATE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 31 January 2008
- Application: ANDA078002
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: CAFFEINE CITRATE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 30 September 2009
- Application: ANDA090357
- Marketing authorisation holder: SUN PHARM
- Local brand name: CAFFEINE CITRATE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 29 August 2012
- Application: ANDA091102
- Marketing authorisation holder: SAGENT PHARMS
- Local brand name: CAFFEINE CITRATE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 29 August 2012
- Application: ANDA090827
- Marketing authorisation holder: SAGENT PHARMS
- Local brand name: CAFFEINE CITRATE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 16 December 2019
- Application: ANDA213202
- Marketing authorisation holder: MICRO LABS
- Local brand name: CAFFEINE CITRATE
- Indication: SOLUTION — ORAL
- Status: approved
FDA
- Status: approved
Vivarin 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 Vivarin approved in United States?
Yes. FDA authorised it on 21 September 2006; FDA authorised it on 20 July 2007; FDA authorised it on 31 January 2008.
Who is the marketing authorisation holder for Vivarin in United States?
EXELA PHARMA SCIENCE holds the US marketing authorisation.