Controls severe or incapacitating allergic conditions. ANDA 83677, held by Mylan. Prednisone.
As of Nov 14, 2026, ANDA 83677 (Prednisone), held by Mylan, was first approved by FDA on Feb 26, 1974, with 35 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Prednisone tablets 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 26, 1974 | Original application | Approved | None posted |
| Prednisone20MG · tablet;oral | Prednisone | Rx |
| Prednisone5MG · tablet;oral | Prednisone | Rx |
| Prednisone10MG · tablet;oral | Prednisone | Rx |
| Jun 5, 2024 | Supplement 69Labeling · Standard review | Approved | None posted |
| May 31, 2024 | Supplement 58Labeling · Standard review | Approved | None posted |
| May 31, 2024 | Supplement 57Labeling · Standard review | Approved | None posted |
| May 31, 2024 | Supplement 56Labeling · Standard review | Approved | None posted |
| Feb 21, 2019 | Supplement 60Manufacturing | Approved | None posted |
| Apr 10, 2002 | Supplement 44Manufacturing | Approved | None posted |
| Nov 13, 2000 | Supplement 40Manufacturing | Approved | None posted |
| Mar 3, 2000 | Supplement 43Manufacturing | Approved | None posted |
| Oct 1, 1998 | Supplement 42Manufacturing | Approved | None posted |
| Jun 29, 1998 | Supplement 41Manufacturing | Approved | None posted |
| Nov 18, 1997 | Supplement 39Manufacturing | Approved | None posted |
| Nov 14, 1994 | Supplement 38Labeling | Approved | None posted |
| Jul 6, 1994 | Supplement 34Manufacturing | Approved | None posted |
| Jul 6, 1994 | Supplement 33Labeling | Approved | None posted |
| Jul 6, 1994 | Supplement 32Manufacturing | Approved | None posted |
| Apr 14, 1994 | Supplement 36Manufacturing | Approved | None posted |
| Feb 9, 1994 | Supplement 37Labeling | Approved | None posted |
| Apr 11, 1991 | Supplement 35Labeling | Approved | None posted |
| Feb 5, 1991 | Supplement 31Manufacturing | Approved | None posted |
| May 17, 1990 | Supplement 23Labeling | Approved | None posted |
| Sep 25, 1989 | Supplement 30Labeling | Approved | None posted |
| Sep 25, 1989 | Supplement 29Manufacturing | Approved | None posted |
| Sep 25, 1989 | Supplement 28Manufacturing | Approved | None posted |
| Sep 25, 1989 | Supplement 27Labeling | Approved | None posted |
| Sep 25, 1989 | Supplement 26Manufacturing | Approved | None posted |
| Sep 25, 1989 | Supplement 25Manufacturing | Approved | None posted |
| Sep 25, 1989 | Supplement 24Manufacturing | Approved | None posted |
| Mar 5, 1987 | Supplement 22Manufacturing | Approved | None posted |
| Mar 5, 1987 | Supplement 21Manufacturing | Approved | None posted |
| Mar 5, 1987 | Supplement 20Manufacturing | Approved | None posted |
| Mar 5, 1987 | Supplement 19Manufacturing | Approved | None posted |
| Mar 5, 1987 | Supplement 18Manufacturing | Approved | None posted |
| Jun 6, 1983 | Supplement 16Manufacturing | Approved | None posted |
| Jul 27, 1982 | Supplement 14Manufacturing | Approved | None posted |
| Jul 27, 1982 | Supplement 13Manufacturing | Approved | None posted |
| Feb 26, 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
