FDA — authorised 24 May 1984
- Application: NDA050554
- Marketing authorisation holder: BRISTOL
- Local brand name: PRECEF
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Bl-S786R in United States
FDA authorised Bl-S786R on 24 May 1984
Marketing authorisations
FDA
- Status: approved
FDA
- Application: ANDA062579
- Marketing authorisation holder: APOTHECON
- Local brand name: PRECEF
- Indication: INJECTABLE — INJECTION
- Status: approved
Bl-S786R 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 Bl-S786R approved in United States?
Yes. FDA authorised it on 24 May 1984; FDA has authorised it; FDA has authorised it.
Who is the marketing authorisation holder for Bl-S786R in United States?
BRISTOL holds the US marketing authorisation.