Approved Drug Products containing 78480 listed in the FDA Orange Book. Original Data : FDA Website

Question

Looking for FDA Orange Book APPLICATION 78480

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 BRIMONIDINE TARTRATE, with a corresponding application number 78480.

Regulatory Information RX

With a dosage strength 0.1%

Dosage Form Route SOLUTION/DROPS; OPHTHALMIC

Reference Listed Drug No

Approved since 2022-12-21

Therapeutic Equivalence (TE) Code AB