Approved Drug Products containing 205494 listed in the FDA Orange Book. Original Data : FDA Website

Question

Looking for FDA Orange Book APPLICATION 205494

score 19 · Accepted Answer

Sanofi, based in France, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

They are recognized for Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

One of their notable products is ELIGLUSTAT TARTRATE, with a corresponding application number 205494.

Regulatory Information RX

With a dosage strength EQ 84MG BASE

Dosage Form Route CAPSULE; ORAL

Reference Listed Drug Yes

Approved since 2014-08-19

Therapeutic Equivalence (TE) Code AB