Approved Drug Products containing 76934 listed in the FDA Orange Book. Original Data : FDA Website

Question

Looking for FDA Orange Book APPLICATION 76934

score 19 · Accepted Answer

ACI HealthCare Limited, based in Bangladesh, is a pharmaceutical company.

One of their notable products is SERTRALINE HYDROCHLORIDE, with a corresponding application number 76934.

Regulatory Information RX

With a dosage strength EQ 20MG BASE/ML

Dosage Form Route CONCENTRATE; ORAL

Reference Listed Drug No

Approved since 2006-06-30

Therapeutic Equivalence (TE) Code AA