FDA — authorised 6 May 1946
- Marketing authorisation holder: AKORN
- Status: approved
🇺🇸 Bal in United States
FDA authorised Bal on 6 May 1946
Marketing authorisations
FDA — authorised 6 May 1946
- Application: NDA005939
- Marketing authorisation holder: PROVEPHARM SAS
- Local brand name: BAL
- Indication: INJECTABLE — INJECTION
- Status: approved
Bal in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Nephrology approved in United States
Frequently asked questions
Is Bal approved in United States?
Yes. FDA authorised it on 6 May 1946; FDA authorised it on 6 May 1946.
Who is the marketing authorisation holder for Bal in United States?
AKORN holds the US marketing authorisation.