The approval is for Ibrutinib tablets 560 mg, 420 mg, 280 mg and 140 mg strengths
NATCO's partner BPI plans to launch 2.5 mg, 5 mg and 7.5 mg strengths of the product shortly within the next few weeks.
ranules now has a total of 38 ANDA approvals from US FDA.
The company will review FDA's response and decide on appropriate next steps soon.
Granules now has a total of 37 ANDA approvals from US FDA (36 Final approvals and 1 tentative approvals).
Subscribe To Our Newsletter & Stay Updated
