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Firm is requesting permission to submit an ANDA for a 5 mg/5 ml prednisolone syrup and asking FDA to approve a waiver from in vivo bioavailability studies. Muro says it conducted in vivo bioavailability studies for a 15 mg/5 ml prednisolone syrup and a 5 mg/5 ml prednisone syrup, which contain identical excipients at approximate concentrations as the proposed product.
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