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Jubilant Life Sciences receives ANDA final approval for Paroxetine Tablets

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FRom USFDA

Jubilant Life Sciences has received Abbreviated New Drug Application (ANDA) final approval from the US Food and Drug Administration (US FDA) for Paroxetine Tablets USP, 10 mg, 20 mg, 30 mg and 40 mg, the generic version of Paxil Tablets, 10 mg, 20 mg, 30 mg, and 40 mg (of Apotex), which is used as an antidepressant.

As on 30 September 2015, Jubilant Life Sciences had a total of 820 filings for formulations of which 391 have been approved in various regions globally. This includes 71 ANDAs filed in the US, of which 39 have been approved and 46 Dossier filings in Europe.

 

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First Published: Dec 01 2015 | 11:46 AM IST

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