Controls severe or incapacitating allergic conditions. ANDA 219509, held by Tp Anda Holdings. Prednisolone.
As of Nov 15, 2026, ANDA 219509 (Prednisolone), held by Tp Anda Holdings, was first approved by FDA on Jun 23, 2025, with 1 approved supplement 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 |
|---|---|---|---|
| Jun 23, 2025 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Prednisolone15MG/5ML · solution;oral | Prednisolone | Rx |
| Apr 27, 2026 | Supplement 1Manufacturing | Approved | None posted |
| Jun 23, 2025 | 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
