Approved Drug Products containing 201846 listed in the FDA Orange Book. Original Data : FDA Website

Question

Looking for FDA Orange Book APPLICATION 201846

score 19 · Accepted Answer

Apotex Inc, based in Canada, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is AZELASTINE HYDROCHLORIDE, with a corresponding application number 201846.

Regulatory Information DISCN

With a dosage strength 0.2055MG/SPRAY

Dosage Form Route SPRAY, METERED; NASAL

Reference Listed Drug No

Approved since 2012-08-31