FDA — authorised 27 September 1993
- Application: NDA020201
- Marketing authorisation holder: HOSPIRA
- Local brand name: DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Dobutamine Hydrochloride In Dextrose 5% In Plastic Container in United States
FDA authorised Dobutamine Hydrochloride In Dextrose 5% In Plastic Container on 27 September 1993
Marketing authorisations
FDA — authorised 27 September 1993
- Application: NDA020255
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 September 1993
- Application: NDA020269
- Marketing authorisation holder: HOSPIRA
- Local brand name: DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 19 October 1993
- Application: ANDA074206
- Marketing authorisation holder: TEVA PARENTERAL
- Local brand name: DOBUTAMINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 October 1994
- Application: ANDA074277
- Marketing authorisation holder: HIKMA
- Local brand name: DOBUTAMINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 February 1995
- Application: ANDA074292
- Marketing authorisation holder: HOSPIRA
- Local brand name: DOBUTAMINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 September 1996
- Application: ANDA074634
- Marketing authorisation holder: HOSPIRA
- Local brand name: DOBUTAMINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 18 February 1998
- Application: ANDA074279
- Marketing authorisation holder: WATSON LABS INC
- Local brand name: DOBUTAMINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 December 2022
- Application: ANDA216131
- Marketing authorisation holder: SLATE RUN PHARMA
- Local brand name: DOBUTAMINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
Dobutamine Hydrochloride In Dextrose 5% In Plastic Container in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Dobutamine Hydrochloride In Dextrose 5% In Plastic Container approved in United States?
Yes. FDA authorised it on 27 September 1993; FDA authorised it on 27 September 1993; FDA authorised it on 27 September 1993.
Who is the marketing authorisation holder for Dobutamine Hydrochloride In Dextrose 5% In Plastic Container in United States?
HOSPIRA holds the US marketing authorisation.