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Oxazepam ANDA suitability petitions

Executive Summary

Zenith and Barr are seeking permission to file ANDAs for oxazepam in 10 mg, 15 mg and 30 mg capsules. The listed drug is Wyeth's Serax, which the company markets in 15 mg tablets and 10 mg, 15 mg, and 30 mg capsules. Barr stated in its petition that it is aware FDA requested Wyeth to reformulate its capsules to be bioequivalent to the 15 mg tablets. Barr said FDA has "already" found Barr's oxazepam 30 mg capsules to be bioequivalent to two Wyeth 15 mg tablets.
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PS012039

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