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Lupin gets FDA approval for treatment of skin infections

Lupin announced that it has received final approval for its Nystatin and Triamcinolone Acetonide Cream USP, 100,000 units/gram and 1mg/gram, from the United States Food and Drug Administration to market a generic version of Delcor Asset Corporation’s (Delcor) Mycolog-II Cream.

BALTIMORE — Lupin announced that it has received final approval for its Nystatin and Triamcinolone Acetonide Cream USP, 100,000 units/gram and 1mg/gram, from the United States Food and Drug Administration to market a generic version of Delcor Asset Corporation’s (Delcor) Mycolog-II Cream.

Lupin’s Nystatin and Triamcinolone Acetonide Cream USP, 100,000 units/gram and 1mg/gram, is the generic equivalent of Delcor’s Mycolog-II Cream. It is indicated for the treatment of cutaneous candidiasis.

Nystatin and Triamcinolone Acetonide Cream USP, 100,000 units/gram and 1mg/gram, had annual sales of approximately USD 62.2 million in the US (IQVIA MAT April 2018).

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