FDA — authorised 19 February 1970
- Application: NDA016812
- Marketing authorisation holder: PH HEALTH
- Local brand name: KETALAR
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Ketalar in United States
FDA authorised Ketalar on 19 February 1970
Marketing authorisations
FDA — authorised 3 June 2020
- Application: ANDA074524
- Marketing authorisation holder: HIKMA
- Indication: Labeling
- Status: approved
FDA — authorised 13 January 2023
- Application: ANDA215808
- Marketing authorisation holder: FRESENIUS KABI USA
- Status: approved
FDA — authorised 24 January 2023
- Application: ANDA216809
- Marketing authorisation holder: GLAND
- Status: approved
FDA — authorised 17 September 2025
- Application: ANDA219684
- Marketing authorisation holder: BAXTER HLTHCARE CORP
- Status: approved
Ketalar in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Ketalar approved in United States?
Yes. FDA authorised it on 19 February 1970; FDA authorised it on 3 June 2020; FDA authorised it on 13 January 2023.
Who is the marketing authorisation holder for Ketalar in United States?
PH HEALTH holds the US marketing authorisation.