Jubilant Life Sciences Ltd has received final approval from the US health regulator for its generic version of anti-depressant Paxil tablets.
The final approval for the abbreviated new drug application (ANDA) from the US Food and Drug Administration (USFDA) for Paroxetine tablets of Apotex is for strengths of 10 mg, 20 mg, 30 mg and 40 mg, the company said in a BSE filing.
As on September 30, 2015, Jubilant Life Sciences had 820 filings for formulations, of which 391 have been approved in various regions globally.
These include 71 ANDAs filed in the US, of which 39 have been approved and 46 Dossier filings in Europe, it added.
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