Approved Drug Products containing 203918 listed in the FDA Orange Book. Original Data : FDA Website

Question

Looking for FDA Orange Book APPLICATION 203918

score 19 · Accepted Answer

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

One of their notable products is SODIUM PHENYLBUTYRATE, with a corresponding application number 203918.

Regulatory Information RX

With a dosage strength 3GM/TEASPOONFUL

Dosage Form Route POWDER; ORAL

Reference Listed Drug No

Approved since 2016-06-15

Therapeutic Equivalence (TE) Code AB