Grant of Permission to manufacture and market FDC of Naproxen Delayed Release and Esomeprazole capsule (375mg/500mg + 20mg/20mg)
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Naproxen Sodium Capsules, 220 mg, of Bionpharma
One batch has 11.4 million units of Naproxen tablets out of which 0.9 million units that were released into the market were recalled
It is part of the company’s pain/analgesics portfolio of OTC products
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