Approved Drug Products containing 201522 listed in the FDA Orange Book. Original Data : FDA Website

Question

Looking for FDA Orange Book APPLICATION 201522

score 19 · Accepted Answer

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

One of their notable products is MONTELUKAST SODIUM, with a corresponding application number 201522.

Regulatory Information RX

With a dosage strength EQ 10MG BASE

Dosage Form Route TABLET; ORAL

Reference Listed Drug No

Approved since 2012-08-03

Therapeutic Equivalence (TE) Code AB