Controls severe or incapacitating allergic conditions. ANDA 40571, held by Pharm Assoc. Prednisolone.
As of Nov 15, 2026, ANDA 40571 (Prednisolone), held by Pharm Assoc, was first approved by FDA on Aug 25, 2005, with 2 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Prednisolone Oral Solution USP is indicated in the following conditions: 1. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice: synthetic analogs may be used in conjunction with mineralocorticoids where applicable: in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia Nonsuppurative thyroiditis Hypercalcemia associated with cancer 2.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 25, 2005 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Prednisolone15MG/5ML · solution;oral | Prednisolone | Rx |
| Feb 13, 2025 | Supplement 5Manufacturing | Approved | None posted |
| Jun 5, 2024 | Supplement 4Labeling · Standard review | Approved | None posted |
| Aug 25, 2005 | 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
