Aleor receives USFDA approval for Nystatin and Triamcinolone Acetonide Cream
Alembic Pharmaceuticals (Alembic) today announced that its joint venture Aleor Dermaceuticals (Aleor) 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. Nystatin and Triamcinolone Acetonide Cream, USP is indicated for the treat...