FDA — authorised 22 August 1978
- Application: NDA017857
- Marketing authorisation holder: APOTHECON
- Local brand name: STADOL PRESERVATIVE FREE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Stadol Preservative Free in United States
FDA authorised Stadol Preservative Free on 22 August 1978
Marketing authorisations
FDA — authorised 7 January 2000
- Application: ANDA074626
- Marketing authorisation holder: HOSPIRA
- Indication: Labeling
- Status: approved
FDA — authorised 6 May 2009
- Application: ANDA075499
- Marketing authorisation holder: APOTEX
- Indication: Labeling
- Status: approved
FDA — authorised 16 December 2016
- Application: ANDA078400
- Marketing authorisation holder: HIKMA FARMACEUTICA
- Indication: Labeling
- Status: approved
FDA — authorised 23 March 2017
- Application: ANDA075824
- Marketing authorisation holder: HIKMA
- Indication: Labeling
- Status: approved
Stadol Preservative Free 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 Stadol Preservative Free approved in United States?
Yes. FDA authorised it on 22 August 1978; FDA authorised it on 7 January 2000; FDA authorised it on 6 May 2009.
Who is the marketing authorisation holder for Stadol Preservative Free in United States?
APOTHECON holds the US marketing authorisation.