Approved Drug Products containing 209830 listed in the FDA Orange Book. Original Data : FDA Website

Question

Looking for FDA Orange Book APPLICATION 209830

score 19 · Accepted Answer

Alkermes Plc, based in Ireland, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is ARIPIPRAZOLE LAUROXIL, with a corresponding application number 209830.

Regulatory Information RX

With a dosage strength 675MG/2.4ML (281.25MG/ML)

Dosage Form Route SUSPENSION, EXTENDED RELEASE; INTRAMUSCULAR

Reference Listed Drug Yes

Approved since 2018-06-29