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Dr Reddy's announces final approval of Ondansetron tablets with 180-Days of marketing exclusivity.
(From Chemical Business NewsBase - Press Release)
Dr Reddy's Laboratories Limited announced, that the US Food and Drug Administration has granted final approval for the company's Abbreviated New Drug Application(ANDA) for Ondansetron Hydrochloride Tablets, 4 mg, 8mg, 16 mg and 24 mg. As the first company to file an ANDA containing a paragraph IV certification for this product, Dr Reddy's has been awarded a 180-day period of marketing exclusivity. The company will commence the shipment of this product shortly. …
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