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Chelsea ANDA withdrawals

Executive Summary

FDA is proposing to withdraw nine ANDAs of the West Hempstead, New York-based generics manufacturer on the grounds that the applications contained untrue statements and that the products are not safe and effective. The ANDAs include verapamil 80 mg and 120 mg tablets (Calan), disopyramide 100 mg and 150 mg capsules (Norpace), perphenazine 4 mg/amitriptyline 50 mg tablets (Tiavil), oxazepam 10, 15 and 30 mg tablets (Serax), and perphenzing 8 mg tablets (Tilafon). Chelsea has until July 23 to request a hearing.

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