Approved Drug Products containing 203634 listed in the FDA Orange Book. Original Data : FDA Website

Question

Looking for FDA Orange Book APPLICATION 203634

score 19 · Accepted Answer

Salix Pharmaceuticals, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is BUDESONIDE, with a corresponding application number 203634.

Regulatory Information RX

With a dosage strength 9MG

Dosage Form Route TABLET, EXTENDED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2013-01-14

Therapeutic Equivalence (TE) Code AB