Approved Drug Products containing 208399 listed in the FDA Orange Book. Original Data : FDA Website

Question

Looking for FDA Orange Book APPLICATION 208399

score 19 · Accepted Answer

TerSera Therapeutics, based in U.S.A, is a pharmaceutical company.

One of their notable products is ROLAPITANT HYDROCHLORIDE, with a corresponding application number 208399.

Regulatory Information DISCN

With a dosage strength EQ 166.5MG BASE/92.5ML (EQ 1.8MG BASE/ML)

Dosage Form Route EMULSION; INTRAVENOUS

Reference Listed Drug Yes

Approved since 2017-10-25