• Lupin gets approval from USFDA for Levothyroxine Sodium tablets

    • September 21, 2019
    • Posted By : admin
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    •   94 views

    Pharma major Lupin Limited has received approval for its ANDA for Levothyroxine Sodium Tablets USP, 25 meg, 50 meg, 75 meg, 88 meg, 100 meg, 112 meg, 125 meg, 137 meg, 150 meg, 175 meg, 200 meg, and 300 meg, from USFDA, to market a generic equivalent of UNITHROID 25 meg, SO meg, 7S meg, 88 meg, 100 meg, 112 meg, 12S meg, 137 meg, 1SO meg, 175 meg, 200 meg, and 300 meg, manufactured by Jerome Stevens Pharmaceuticals Inc.

    Lupin’s Levothyroxine Sodium Tablets USP, 25 meg, SO meg, 7S meg, 88 meg, 100 meg, 112 meg, 12S meg, 137 meg, 1SO meg, 175 meg, 200 meg, and 300 meg was originally approved on January 18, 2019 as generic equivalent of SYNTHROID 25 meg, SO meg, 7S meg, 88 meg, 100 meg, 112 meg, 12S meg, 137 meg, 1SO meg, 17S meg, 200 meg, and 300 meg, manufactured by ABBVIE Inc.

    With this sANDA approval, Lupin’s Levothyroxine Sodium Tablets USP, 2S meg, SO meg, 7S meg, 88 meg, 100 meg, 112 meg, 125 meg, 137 meg, 1SO meg, 17S meg, 200 meg, and 300 meg are now AB rated (therapeutically equivalent) with Reference Listed Drugs, SYNTHROID and UNITHROID.

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