Approved Drug Products containing 209345 listed in the FDA Orange Book. Original Data : FDA Website

Question

Looking for FDA Orange Book APPLICATION 209345

score 19 · Accepted Answer

Actavis Inc, based in Ireland, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is PIMECROLIMUS, with a corresponding application number 209345.

Regulatory Information RX

With a dosage strength 1%

Dosage Form Route CREAM; TOPICAL

Reference Listed Drug No

Approved since 2018-12-27

Therapeutic Equivalence (TE) Code AB