Controls severe or incapacitating allergic conditions. ANDA 218083, held by Zhejiang Xianju. Prednisolone.
As of Nov 15, 2026, ANDA 218083 (Prednisolone), held by Zhejiang Xianju, was first approved by FDA on May 2, 2024, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE 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. Rheumatic disorders.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 2, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Prednisolone5MG · tablet;oral | Prednisolone | Rx |
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
