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Aurobindo Pharma receives ANDA approval for Risedronate Sodium Tablets

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Capital Market

From USFDA

Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Risedronate Sodium Tablets USP, 5 mg, 30 mg and 35 mg (ANDA 200296). This approval is an extension of tentative approval received on 10 October 2012. This product is ready for launch.

The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) ACTONEL Tablets of Warner Chilcott Co., LLC

Risedronate Sodium Tablets are used in the treatment of Osteoporosis.

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First Published: Dec 01 2015 | 4:48 PM IST

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