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)
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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)
Dockets · As of Jun 30, 2026
The source record
As of Jun 30, 2026; may be out of date.
- Docket type
- Nonrulemaking
- Title
- 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)
- Ingested at
- 2026-06-30T05:22:16.053483+00:00
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| Dockets | What this connects to | 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) has a recorded connection to Dockets. | None |