Alembic Pharma JV gets USFDA nod to Nystatin and Triamcinolone Acetonide Cream
Mumbai: Drug major, Alembic Pharmaceuticals Limited, today announced that the company's joint venture Aleor Dermaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Nystatin and Triamcinolone Acetonide Cream USP, 100,000 units/gram and 1 mg/gram. The approved ANDA is therapeutically equivalent to...
Mumbai: Drug major, Alembic Pharmaceuticals Limited, today announced that the company's joint venture Aleor Dermaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Nystatin and Triamcinolone Acetonide Cream USP, 100,000 units/gram and 1 mg/gram.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Nystatin and Triamcinolone Acetonide Cream USP, 100,000 units/gram and 1 mg/gram, of Taro Pharmaceuticals U.S.A. Inc.
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