FDA — authorised 19 September 1973
- Marketing authorisation holder: OAK PHARMS
- Status: approved
🇺🇸 Nembutal Sodium in United States
FDA authorised Nembutal Sodium on 19 September 1973
Marketing authorisations
FDA — authorised 14 January 1975
- Application: ANDA084093
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: NEMBUTAL SODIUM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 February 1975
- Application: ANDA084095
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: NEMBUTAL SODIUM
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 27 April 2017
- Application: ANDA206404
- Marketing authorisation holder: SAGENT PHARMS INC
- Indication: Labeling
- Status: approved
FDA — authorised 13 November 2017
- Application: ANDA203619
- Marketing authorisation holder: HIKMA
- Status: approved
Nembutal Sodium 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 Nembutal Sodium approved in United States?
Yes. FDA authorised it on 19 September 1973; FDA authorised it on 14 January 1975; FDA authorised it on 18 February 1975.
Who is the marketing authorisation holder for Nembutal Sodium in United States?
OAK PHARMS holds the US marketing authorisation.