Approved Drug Products containing 207979 listed in the FDA Orange Book. Original Data : FDA Website

Question

Looking for FDA Orange Book APPLICATION 207979

score 19 · Accepted Answer

Biocon, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is FINGOLIMOD HYDROCHLORIDE, with a corresponding application number 207979.

Regulatory Information RX

With a dosage strength EQ 0.5MG BASE

Dosage Form Route CAPSULE; ORAL

Reference Listed Drug No

Approved since 2019-12-04

Therapeutic Equivalence (TE) Code AB