Controls severe or incapacitating allergic conditions. ANDA 80531, held by Chartwell Molecular. Prednisolone.
As of Nov 15, 2026, ANDA 80531 (Prednisolone), held by Chartwell Molecular, was first approved by FDA on May 31, 1974, with 9 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 31, 1974 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Prednisolone5MG · tablet;oral | Prednisolone | Rx |
| Jun 5, 2024 | Supplement 15Labeling · Standard review | Approved | None posted |
| Oct 2, 2002 | Supplement 13Manufacturing | Approved | None posted |
| Sep 25, 2001 | Supplement 9Manufacturing | Approved | None posted |
| Sep 25, 2001 | Supplement 10Labeling | Approved | None posted |
| Sep 25, 2001 | Supplement 11Manufacturing | Approved | None posted |
| Sep 25, 2001 | Supplement 12Manufacturing | Approved | None posted |
| Aug 10, 2000 | Supplement 8Manufacturing | Approved | None posted |
| Jun 25, 1992 | Supplement 7Manufacturing | Approved | None posted |
| May 23, 1988 | Supplement 6Labeling | Approved | None posted |
| May 31, 1974 | 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
