FDA — authorised 28 February 1973
- Application: NDA016931
- Marketing authorisation holder: PHARMACIA AND UPJOHN
- Local brand name: R-GENE 10
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 R-Gene 10 in United States
FDA authorised R-Gene 10 on 28 February 1973
Marketing authorisations
FDA
- Status: approved
R-Gene 10 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 R-Gene 10 approved in United States?
Yes. FDA authorised it on 28 February 1973; FDA has authorised it.
Who is the marketing authorisation holder for R-Gene 10 in United States?
PHARMACIA AND UPJOHN holds the US marketing authorisation.