Approved Drug Products containing 215003 listed in the FDA Orange Book. Original Data : FDA Website

Question

Looking for FDA Orange Book APPLICATION 215003

score 19 · Accepted Answer

Novitium Pharma LLC, based in U.S.A, is a pharmaceutical company.

One of their notable products is PAROXETINE HYDROCHLORIDE, with a corresponding application number 215003.

Regulatory Information RX

With a dosage strength EQ 10MG BASE/5ML

Dosage Form Route SUSPENSION; ORAL

Reference Listed Drug No

Approved since 2021-09-03

Therapeutic Equivalence (TE) Code AB