FDA — authorised 11 June 1970
- Marketing authorisation holder: AKORN INC
- Status: approved
🇺🇸 Inapsine in United States
FDA authorised Inapsine on 11 June 1970
Marketing authorisations
FDA — authorised 11 June 1970
- Application: NDA016796
- Marketing authorisation holder: RISING
- Local brand name: INAPSINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 November 1986
- Application: ANDA070993
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: DROPERIDOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 November 1986
- Application: ANDA070992
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: DROPERIDOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 April 1988
- Application: ANDA071645
- Marketing authorisation holder: HOSPIRA
- Local brand name: DROPERIDOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 6 September 1988
- Application: ANDA071750
- Marketing authorisation holder: SMITH AND NEPHEW
- Local brand name: DROPERIDOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 October 1988
- Application: ANDA072335
- Marketing authorisation holder: LUITPOLD
- Local brand name: DROPERIDOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 October 1988
- Application: ANDA072123
- Marketing authorisation holder: AM REGENT
- Local brand name: DROPERIDOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 August 1995
- Application: ANDA072272
- Marketing authorisation holder: HOSPIRA
- Local brand name: DROPERIDOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 14 December 2017
- Application: ANDA208197
- Marketing authorisation holder: HIKMA
- Local brand name: DROPERIDOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA073520
- Marketing authorisation holder: WATSON LABS
- Local brand name: DROPERIDOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA073521
- Marketing authorisation holder: WATSON LABS
- Local brand name: DROPERIDOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA073523
- Marketing authorisation holder: WATSON LABS
- Local brand name: DROPERIDOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA072028
- Marketing authorisation holder: ASTRAZENECA
- Local brand name: FENTANYL CITRATE AND DROPERIDOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA071941
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: DROPERIDOL
- Indication: Injectable — Injection
- Status: approved
FDA
- Application: ANDA071942
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: DROPERIDOL
- Indication: Injectable — Injection
- Status: approved
FDA
- Application: NDA016049
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: INNOVAR
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA071754
- Marketing authorisation holder: SOLOPAK
- Local brand name: DROPERIDOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA071755
- Marketing authorisation holder: SOLOPAK
- Local brand name: DROPERIDOL
- Indication: INJECTABLE — INJECTION
- Status: approved
Inapsine 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 Inapsine approved in United States?
Yes. FDA authorised it on 11 June 1970; FDA authorised it on 11 June 1970; FDA authorised it on 17 November 1986.
Who is the marketing authorisation holder for Inapsine in United States?
AKORN INC holds the US marketing authorisation.