Approved Drug Products containing 79142 listed in the FDA Orange Book. Original Data : FDA Website

Question

Looking for FDA Orange Book APPLICATION 79142

Viatris, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is MONTELUKAST SODIUM, with a corresponding application number 79142.

Regulatory Information DISCN

With a dosage strength EQ 4MG BASE

Dosage Form Route TABLET, CHEWABLE; ORAL

Reference Listed Drug No

Approved since 2012-08-03

score 19 · Accepted Answer

Viatris, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is MONTELUKAST SODIUM, with a corresponding application number 79142.

Regulatory Information DISCN

With a dosage strength EQ 5MG BASE

Dosage Form Route TABLET, CHEWABLE; ORAL

Reference Listed Drug No

Approved since 2012-08-03