FDA — authorised 18 July 1978
- Status: approved
🇺🇸 Dobutamine Hydrochloride In Dextrose 5% In Plastic Container in United States
FDA authorised Dobutamine Hydrochloride In Dextrose 5% In Plastic Container on 18 July 1978
Marketing authorisations
FDA — authorised 27 September 1993
- Application: NDA020255
- Marketing authorisation holder: BAXTER HLTHCARE
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
FDA — authorised 2 December 1996
- Application: ANDA074086
- Marketing authorisation holder: HOSPIRA
- Indication: Labeling
- Status: approved
FDA — authorised 26 February 1997
- Application: ANDA074277
- Marketing authorisation holder: HIKMA
- Indication: Labeling
- Status: approved
FDA — authorised 28 October 1998
- Application: NDA020201
- Marketing authorisation holder: HOSPIRA
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 21 December 2022
- Application: ANDA216131
- Marketing authorisation holder: SLATE RUN PHARMA
- 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 18 July 1978; FDA authorised it on 27 September 1993; FDA authorised it on 2 December 1996.
Who is the marketing authorisation holder for Dobutamine Hydrochloride In Dextrose 5% In Plastic Container in United States?
Marketing authorisation holder not available in our data.