Controls severe or incapacitating allergic conditions. ANDA 215673, held by Aurobindo Pharma Ltd. Prednisolone.
As of Nov 15, 2026, ANDA 215673 (Prednisolone), held by Aurobindo Pharma Ltd, was first approved by FDA on Mar 17, 2023, with 1 approved supplement 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 |
|---|---|---|---|
| Mar 17, 2023 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Prednisolone5MG · tablet;oral | Prednisolone | Rx |
| Jun 5, 2024 | Supplement 1Labeling · Standard review | Approved | None posted |
| Mar 17, 2023 | 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
