Approved Drug Products containing 209531 listed in the FDA Orange Book. Original Data : FDA Website

Question

Looking for FDA Orange Book APPLICATION 209531

score 19 · Accepted Answer

Biogen, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA and WHO-GMP.

One of their notable products is NUSINERSEN SODIUM, with a corresponding application number 209531.

Regulatory Information RX

With a dosage strength EQ 12MG BASE/5ML (EQ 2.4MG BASE/ML)

Dosage Form Route SOLUTION; INTRATHECAL

Reference Listed Drug Yes

Approved since 2016-12-23