The product is a generic version of King Pharmaceuticals Research and Development LLC's Levoxyl tablets in same strengths, Lupin said.
With this approval, the company's product is now generic version of ABBVIE Inc's Synthroid tablets, Jerome Stevens Pharmaceuticals Inc's Unithroid tablets and Levoxyl tablets of King Pharmaceuticals Research and Development LLC, it added.
It is the only product approved with FDA's new narrow therapeutic index guidance for Levothyroxine, Lupin said.
The cumulatively Levothyroxine Sodium tablets USP had annual sales of around USD 2,581 million in the US, Lupin said.
Shares of Lupin Ltd closed at Rs 765.70 per scrip on the BSE, up 2.69 per cent from its previous close.
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