FDA
- Status: approved
probiotic containing L.rhamnosus R0011 strain (probiotic containing L.rhamnosus R0011 strain) regulatory status in United States.
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA has authorised it.
University of Michigan is the originator. The local marketing authorisation holder may differ — check the official source linked above.