FDA Approves ANDA078416 for Prednisolone Sodium Phosphate Oral Solution

The U.S. Food and Drug Administration issued an approval (status AP) for application number ANDA078416 on October 31, 2007. The submission, filed by Vintage Pharms, pertains to an oral solution of prednisolone sodium phosphate (equivalent to 5 mg base per 5 mL). The product is identified as discontinued in the FDA database. Key details include: - Route: Oral - Dosage form: Solution - Brand name: Prednisolone Sodium Phosphate - Sponsor: Vintage Pharms - Submission type: Original (ORIG) with submission number 1 - Reference drug: No - Reference standard: No