Controls severe or incapacitating allergic conditions. ANDA 40362, held by Jubilant Cadista. Prednisone.
As of Nov 14, 2026, ANDA 40362 (Prednisone), held by Jubilant Cadista, was first approved by FDA on Aug 29, 2001, with 5 approved supplements and 0 published complete response letters.
INDICATIONS Prednisone Tablets, USP are indicated in the following conditions: 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 2.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 29, 2001 | Original application | Approved |
| Prednisone10MG · tablet;oral | Prednisone | Rx |
| Prednisone5MG · tablet;oral | Prednisone | Rx |
| Prednisone20MG · tablet;oral | Prednisone | Rx |
| Prednisone2.5MG · tablet;oral | Prednisone | Rx |
| Prednisone50MG · tablet;oral | Prednisone | Rx |
| Jun 5, 2024 | Supplement 20Labeling · Standard review | Approved | None posted |
| Apr 17, 2023 | Supplement 18Manufacturing | Approved | None posted |
| Jun 29, 2005 | Supplement 3 | Approved | None posted |
| Jun 29, 2005 | Supplement 4Labeling | Approved | None posted |
| May 11, 2004 | Supplement 2Labeling | Approved | None posted |
| Aug 29, 2001 | Original application | Approved |
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
