Approved Drug Products containing 50758 listed in the FDA Orange Book. Original Data : FDA Website

Question

Looking for FDA Orange Book APPLICATION 50758

score 19 · Accepted Answer

F. Hoffmann-La Roche, based in Switzerland, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is MYCOPHENOLATE MOFETIL HYDROCHLORIDE, with a corresponding application number 50758.

Regulatory Information RX

With a dosage strength 500MG/VIAL

Dosage Form Route INJECTABLE; INJECTION

Reference Listed Drug Yes

Approved since 1998-08-12

Therapeutic Equivalence (TE) Code AP