FDA — authorised 25 February 1974
- Status: approved
🇺🇸 Dopamine Hydrochloride in United States
FDA authorised Dopamine Hydrochloride on 25 February 1974
Marketing authorisations
FDA — authorised 10 September 1984
- Application: NDA018132
- Marketing authorisation holder: HOSPIRA
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 28 July 1989
- Application: NDA019615
- Marketing authorisation holder: BAXTER HLTHCARE
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 26 June 1996
- Application: NDA018826
- Marketing authorisation holder: HOSPIRA
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 5 November 2024
- Application: ANDA207707
- Marketing authorisation holder: HIKMA INTL PHARMS
- Indication: Labeling
- Status: approved
The FDA approved Dopamine Hydrochloride, manufactured by HIKMA INTL PHARMS, on 5 November 2024. The approval was granted under the standard expedited pathway. The drug is indicated for use as stated in the labelling. The application number for this approval is ANDA207707.
Dopamine Hydrochloride 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 Dopamine Hydrochloride approved in United States?
Yes. FDA authorised it on 25 February 1974; FDA authorised it on 10 September 1984; FDA authorised it on 28 July 1989.
Who is the marketing authorisation holder for Dopamine Hydrochloride in United States?
Marketing authorisation holder not available in our data.