Approved Drug Products containing 8316 listed in the FDA Orange Book. Original Data : FDA Website

Question

Looking for FDA Orange Book APPLICATION 8316

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 PRIMAQUINE PHOSPHATE, with a corresponding application number 8316.

Regulatory Information RX

With a dosage strength EQ 15MG BASE

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 1982-01-01

Therapeutic Equivalence (TE) Code AB