Approved Drug Products containing 16131 listed in the FDA Orange Book. Original Data : FDA Website

Question

Looking for FDA Orange Book APPLICATION 16131

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 CLOMIPHENE CITRATE, with a corresponding application number 16131.

Regulatory Information DISCN

With a dosage strength 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 1982-01-01