From USFDA
Ajanta Pharma has received final approval for Entacapone Tablets from US FDA. It is a bioequivalent generic version of Comtan1 Tablets. Company will be launching the product shortly in 200mg strength tablets.Entacapone Tablets is part of an ever growing portfolio of products that Ajanta has developed for the US market. In total, Ajanta has 35 Abbreviated New Drug Application (ANDA) of which it has final approvals for 20 ANDAs; tentative approvals for 2 ANDA; and 13 ANDAs are under review with US FDA.
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