Approved Drug Products containing 208065 listed in the FDA Orange Book. Original Data : FDA Website

Question

Looking for FDA Orange Book APPLICATION 208065

AstraZeneca, based in United Kingdom, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is OSIMERTINIB MESYLATE, with a corresponding application number 208065.

Regulatory Information RX

With a dosage strength EQ 40MG BASE

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 2015-11-13

score 19 · Accepted Answer

AstraZeneca, based in United Kingdom, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is OSIMERTINIB MESYLATE, with a corresponding application number 208065.

Regulatory Information RX

With a dosage strength EQ 80MG BASE

Dosage Form Route TABLET; ORAL

Reference Listed Drug Yes

Approved since 2015-11-13