Controls severe or incapacitating allergic conditions. ANDA 40323, held by Chartwell Rx. Prednisolone.
As of Nov 15, 2026, ANDA 40323 (Prednisolone), held by Chartwell Rx, was first approved by FDA on May 13, 1999, with 3 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 |
|---|---|---|---|
| May 13, 1999 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Prednisolone15MG/5ML · solution;oral | Prednisolone | Rx |
| Jun 5, 2024 | Supplement 10Labeling · Standard review | Approved | None posted |
| Jan 22, 2003 | Supplement 5Labeling | Approved | None posted |
| Jan 30, 2002 | Supplement 1Manufacturing | Approved | None posted |
| May 13, 1999 | Original application | Approved |
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
