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
規制動向2026年9月18日•3分で読めます
FDA Approves ANDA078416 for Prednisolone Sodium Phosphate Oral Solution
The FDA granted approval (status AP) for Vintage Pharms' ANDA078416 covering an oral solution of prednisolone sodium phosphate on Oct 31 2007; the product is listed as discontinued.
Pharmacountryチームがまとめました · 出典： FDA.gov
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