Requests that the FDA evaluate the stability and safety at labeled storage conditions of Store at 20C to 25C (68F to 77F) (See USP Controlled Room Temperature) of Kesin Pharma's (Kesin) repackaged Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL unit-dose cups (NDC 81033-021-54)
🏛 Food and Drug Administration (FDA)FDA-2026-P-7013
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- Other· Jun 24, 2026No comment period
- Other· Jun 24, 2026No comment period