Controls severe or incapacitating allergic conditions. ANDA 211496, held by Quagen. Prednisone.
As of Nov 14, 2026, ANDA 211496 (Prednisone), held by Quagen, was first approved by FDA on Dec 28, 2018, with 1 approved supplement and 0 published complete response letters.
INDICATIONS 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 28, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Prednisone1MG · tablet;oral | Prednisone | Discontinued |
| Jun 5, 2024 | Supplement 4Labeling · Standard review | Approved | None posted |
| Dec 28, 2018 | 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
