Controls severe or incapacitating allergic conditions. ANDA 210785, held by Strides Pharma. Prednisone.
As of Nov 14, 2026, ANDA 210785 (Prednisone), held by Strides Pharma, was first approved by FDA on Sep 2, 2020, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Prednisone tablets USP are indicated in the following conditions: 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 |
|---|---|---|---|
| Sep 2, 2020 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Prednisone1MG · tablet;oral | Prednisone | Rx |
| Jun 5, 2024 | Supplement 5Labeling · Standard review | Approved | None posted |
| Sep 2, 2020 | 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
