Approved Drug Products containing 81223 listed in the FDA Orange Book. Original Data : FDA Website

Question

Looking for FDA Orange Book APPLICATION 81223

score 19 · Accepted Answer

Mikart, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA.

They are recognized for As a CDMO, Mikart offers integrated CDMO services for Solid Dose & Non-sterile Liquid formulations.

One of their notable products is ACETAMINOPHEN; HYDROCODONE BITARTRATE, with a corresponding application number 81223.

Regulatory Information DISCN

With a dosage strength 650MG;10MG

Dosage Form Route TABLET; ORAL

Reference Listed Drug No

Approved since 1992-05-29