FDA — authorised 20 August 1956
- Application: NDA008857
- Marketing authorisation holder: WYETH AYERST
- Local brand name: PHENERGAN
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Phenergan in United States
FDA authorised Phenergan on 20 August 1956
Marketing authorisations
FDA — authorised 5 May 1958
- Application: NDA010926
- Marketing authorisation holder: NORVIUM BIOSCIENCE
- Local brand name: PHENERGAN
- Indication: SUPPOSITORY — RECTAL
- Status: approved
FDA — authorised 27 April 1960
- Application: NDA011689
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: PHENERGAN
- Indication: SUPPOSITORY — RECTAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA089013
- Marketing authorisation holder: CENCI
- Local brand name: PROMETHAZINE
- Indication: SYRUP — ORAL
- Status: approved
Phenergan in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Phenergan approved in United States?
Yes. FDA authorised it on 20 August 1956; FDA authorised it on 5 May 1958; FDA authorised it on 27 April 1960.
Who is the marketing authorisation holder for Phenergan in United States?
WYETH AYERST holds the US marketing authorisation.