Approved Drug Products containing 21830 listed in the FDA Orange Book. Original Data : FDA Website

Question

Looking for FDA Orange Book APPLICATION 21830

score 19 · Accepted Answer

AbbVie Inc, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is MESALAMINE, with a corresponding application number 21830.

Regulatory Information DISCN

With a dosage strength 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage Form Route TABLET, DELAYED RELEASE; ORAL

Reference Listed Drug Yes

Approved since 2008-05-29