Controls severe or incapacitating allergic conditions. ANDA 211575, held by Novitium Pharma. Prednisone.
As of Nov 14, 2026, ANDA 211575 (Prednisone), held by Novitium Pharma, was first approved by FDA on Nov 15, 2019, with 1 approved supplement and 0 published complete response letters.
INDICATIONS & 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, Hypercalcemia associated with cancer, nonsuppurative thyroiditis Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases…
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 15, 2019 | Original application | Approved | None posted |
| Prednisone2.5MG · tablet;oral | Prednisone | Rx |
| Prednisone5MG · tablet;oral | Prednisone | Rx |
| Prednisone10MG · tablet;oral | Prednisone | Rx |
| Prednisone20MG · tablet;oral | Prednisone | Rx |
| Prednisone50MG · tablet;oral | Prednisone | Rx |
| Jun 5, 2024 | Supplement 16Labeling · Standard review | Approved | None posted |
| Nov 15, 2019 | 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
