Imatinib Mesylate Product DMF Has Successfully Passed the US FDA Scientific Review

source:TH author:TH Publication time:2018-11-01 browse:2533

September 29, 2018, Tai Heng received official letter from the US FDA,which is in reference to our DMF(#024838)for Imatinib Mesylate. The letter indicated that FDA had completed the full scientific review of this DMF and had found the DMF to be adequate to support an ANDA submission. Tai Heng commites that if there are any future changes to the DMF, we will promptly report to the FDA and inform our customers per 21 CFR 314.420(c).

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