Approved Drug Products containing 208383 listed in the FDA Orange Book. Original Data : FDA Website

Question

Looking for FDA Orange Book APPLICATION 208383

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

One of their notable products is BETRIXABAN, with a corresponding application number 208383.

Regulatory Information DISCN

With a dosage strength 40MG

Dosage Form Route CAPSULE; ORAL

Reference Listed Drug Yes

Approved since 2017-06-23

score 19 · Accepted Answer

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

One of their notable products is BETRIXABAN, with a corresponding application number 208383.

Regulatory Information DISCN

With a dosage strength 80MG

Dosage Form Route CAPSULE; ORAL

Reference Listed Drug Yes

Approved since 2017-06-23