FDA — authorised 27 September 1993
- Application: NDA020269
- Marketing authorisation holder: HOSPIRA
- Local brand name: DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 DOBUTAMINE HYDROCHLORIDE in United States
FDA authorised DOBUTAMINE HYDROCHLORIDE on 27 September 1993 · 1,324 US adverse-event reports
Marketing authorisations
FDA — authorised 19 October 1993
- Application: ANDA074206
- Marketing authorisation holder: TEVA PARENTERAL
- Local brand name: DOBUTAMINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 November 1993
- Application: ANDA074086
- Marketing authorisation holder: HOSPIRA
- 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 21 February 1995
- Application: ANDA074098
- Marketing authorisation holder: TELIGENT
- Local brand name: DOBUTAMINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 September 1996
- Application: ANDA074381
- Marketing authorisation holder: BAXTER HLTHCARE
- 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 31 March 1998
- Application: ANDA074995
- Marketing authorisation holder: DR REDDYS
- Local brand name: DOBUTAMINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 June 1998
- Application: ANDA074545
- Marketing authorisation holder: LUITPOLD
- 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
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 1,324
Most-reported reactions
- Death — 290 reports (21.9%)
- Stress — 140 reports (10.57%)
- Off Label Use — 128 reports (9.67%)
- Sepsis — 121 reports (9.14%)
- Condition Aggravated — 115 reports (8.69%)
- Multiple Organ Dysfunction Syndrome — 109 reports (8.23%)
- Cardiogenic Shock — 108 reports (8.16%)
- Drug Ineffective — 106 reports (8.01%)
- General Physical Health Deterioration — 104 reports (7.85%)
- Ventricular Fibrillation — 103 reports (7.78%)
DOBUTAMINE HYDROCHLORIDE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is DOBUTAMINE HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 27 September 1993; FDA authorised it on 19 October 1993; FDA authorised it on 29 November 1993.
Who is the marketing authorisation holder for DOBUTAMINE HYDROCHLORIDE in United States?
HOSPIRA holds the US marketing authorisation.