FDA — authorised 13 April 1956
- Application: NDA010349
- Marketing authorisation holder: HIKMA
- Local brand name: SPARINE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 PROMAZINE HYDROCHLORIDE in United States
FDA authorised PROMAZINE HYDROCHLORIDE on 13 April 1956
Marketing authorisations
FDA — authorised 8 April 1957
- Application: NDA010348
- Marketing authorisation holder: WYETH AYERST
- Local brand name: SPARINE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 November 1957
- Application: NDA010942
- Marketing authorisation holder: WYETH AYERST
- Local brand name: SPARINE
- Indication: CONCENTRATE — ORAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA084510
- Marketing authorisation holder: WATSON LABS
- Local brand name: PROMAZINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA084517
- Marketing authorisation holder: WATSON LABS
- Local brand name: PROMAZINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
PROMAZINE 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 PROMAZINE HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 13 April 1956; FDA authorised it on 8 April 1957; FDA authorised it on 12 November 1957.
Who is the marketing authorisation holder for PROMAZINE HYDROCHLORIDE in United States?
HIKMA holds the US marketing authorisation.