Approved Drug Products containing 209400 listed in the FDA Orange Book. Original Data : FDA Website

Question

Looking for FDA Orange Book APPLICATION 209400

score 19 · Accepted Answer

Dexcel Pharma, based in Israel, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is OMEPRAZOLE, with a corresponding application number 209400.

Regulatory Information OTC

With a dosage strength 20MG

Dosage Form Route TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2017-07-05