Controls severe or incapacitating allergic conditions. ANDA 40775, held by Lannett Co Inc. Prednisolone.
As of Nov 15, 2026, ANDA 40775 (Prednisolone), held by Lannett Co Inc, was first approved by FDA on Sep 21, 2007, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Prednisolone Syrup (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 |
|---|---|---|---|
| Sep 21, 2007 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Prednisolone15MG/5ML · solution;oral | Prednisolone | Rx |
| Jun 5, 2024 | Supplement 13Labeling · Standard review | Approved | None posted |
| Sep 21, 2007 | 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
