FDA — authorised 17 April 1980
- Marketing authorisation holder: NOVARTIS
- Status: approved
🇺🇸 Oxytocin 5 Usp Units In Dextrose 5% in United States
FDA authorised Oxytocin 5 Usp Units In Dextrose 5% on 17 April 1980
Marketing authorisations
FDA — authorised 23 November 1994
- Application: NDA018248
- Marketing authorisation holder: FRESENIUS KABI USA
- Indication: Labeling
- Status: approved
FDA — authorised 13 February 2013
- Application: ANDA200219
- Marketing authorisation holder: HIKMA FARMACEUTICA
- Indication: Not Applicable
- Status: approved
FDA — authorised 18 June 2014
- Application: NDA018261
- Marketing authorisation holder: PH HEALTH
- Indication: Manufacturing (CMC)
- Status: approved
Oxytocin 5 Usp Units In Dextrose 5% 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 Oxytocin 5 Usp Units In Dextrose 5% approved in United States?
Yes. FDA authorised it on 17 April 1980; FDA authorised it on 23 November 1994; FDA authorised it on 13 February 2013.
Who is the marketing authorisation holder for Oxytocin 5 Usp Units In Dextrose 5% in United States?
NOVARTIS holds the US marketing authorisation.