Controls severe or incapacitating allergic conditions. ANDA 91396, held by Mission Pharma. Prednisolone Sodium Phosphate.
As of Nov 15, 2026, ANDA 91396 (Prednisolone Sodium Phosphate), held by Mission Pharma, was first approved by FDA on Sep 13, 2010, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Prednisolone sodium phosphate oral solution (25 mg prednisolone per 5 mL) is indicated in the following conditions: 1. Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adult and pediatric populations with: seasonal or perennial allergic rhinitis; asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions. 2. Dermatologic Diseases Pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative erythroderma; mycosis fungoides. 3.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 13, 2010 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Prednisolone Sodium PhosphateEQ 25MG BASE/5ML · solution;oral | Prednisolone Sodium Phosphate | Rx |
| Jun 5, 2024 | Supplement 5Labeling · Standard review | Approved | None posted |
| Sep 13, 2010 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
