FDA — authorised 12 October 1948
- Application: NDA006536
- Marketing authorisation holder: TEVA BRANDED PHARM
- Local brand name: URECHOLINE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Urecholine in United States
FDA authorised Urecholine on 12 October 1948
Marketing authorisations
FDA — authorised 29 May 1984
- Application: ANDA088441
- Marketing authorisation holder: ODYSSEY PHARMS
- Local brand name: URECHOLINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 May 1984
- Application: ANDA088440
- Marketing authorisation holder: ODYSSEY PHARMS
- Local brand name: URECHOLINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 December 1985
- Application: ANDA089095
- Marketing authorisation holder: ODYSSEY PHARMS
- Local brand name: URECHOLINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 December 1985
- Application: ANDA089096
- Marketing authorisation holder: ODYSSEY PHARMS
- Local brand name: URECHOLINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 June 2005
- Application: ANDA040635
- Marketing authorisation holder: UPSHER SMITH LABS
- Status: approved
FDA — authorised 1 June 2005
- Application: ANDA040633
- Marketing authorisation holder: UPSHER SMITH LABS
- Status: approved
FDA — authorised 26 October 2007
- Application: ANDA040728
- Marketing authorisation holder: CHARTWELL RX
- Status: approved
FDA — authorised 21 November 2007
- Application: ANDA040855
- Marketing authorisation holder: AMNEAL PHARM
- Status: approved
FDA — authorised 4 May 2010
- Application: ANDA091256
- Marketing authorisation holder: HERITAGE PHARMA
- Status: approved
Urecholine 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 Urecholine approved in United States?
Yes. FDA authorised it on 12 October 1948; FDA authorised it on 29 May 1984; FDA authorised it on 29 May 1984.
Who is the marketing authorisation holder for Urecholine in United States?
TEVA BRANDED PHARM holds the US marketing authorisation.