Approved Drug Products containing 205613 listed in the FDA Orange Book. Original Data : FDA Website

Question

Looking for FDA Orange Book APPLICATION 205613

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 205613.

Regulatory Information RX

With a dosage strength 2MG/ACTUATION

Dosage Form Route AEROSOL, FOAM; RECTAL

Reference Listed Drug Yes

Approved since 2014-10-07

Therapeutic Equivalence (TE) Code AB