Approved Drug Products containing 74978 listed in the FDA Orange Book. Original Data : FDA Website

Question

Looking for FDA Orange Book APPLICATION 74978

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 IBUPROFEN, with a corresponding application number 74978.

Regulatory Information RX

With a dosage strength 100MG/5ML

Dosage Form Route SUSPENSION; ORAL

Reference Listed Drug No

Approved since 1998-03-25

Therapeutic Equivalence (TE) Code AB