The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Soriatane Capsules, 10 mg, 17.5 mg, and 25 mg, of Stiefel Laboratories, Inc. Acitretin capsules are indicated for the treatment of severe psoriasis in adults. Refer label for a detailed indication.
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Alembic Pharmaceuticals receives final US FDA approval for Acitretin Capsules USP, 10 mg, 17.5 mg, 25 mg
August 9, 2024The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Soriatane Capsules, 10 mg, 17.5 mg, and 25 mg, of Stiefel Laboratories, Inc. Acitretin capsules are indicated for the treatment of severe psoriasis in adults. Refer label for a detailed indication.