From USFDA
Ajanta Pharma has received final approval for Omeprazole and Sodium Bicarbonate Powder for Oral Suspension from US FDA. It is a bioequivalent generic version of Zegerid1 Powder for Oral Suspension and the company will be launching the product soon in 2 strengths 20 mg / 1680 mg & 40 mg / 1680 mg Powder Sachets.This new approval is part of an ever growing portfolio of products that Ajanta has developed for the US market. In total, Ajanta has 26 Abbreviated New Drug Application (ANDA) of which it has final approvals for 12 ANDAs; tentative approvals for 1 ANDA; and 13 ANDAs are under review with US FDA.
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