NDA 9766, held by Schering. Prednisone.
As of Nov 13, 2026, NDA 9766 (Meticorten), held by Schering, was first approved by FDA on Feb 21, 1955, with 12 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 21, 1955 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Meticorten5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Prednisone | DiscontinuedReference drug |
| Meticorten1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Prednisone | DiscontinuedReference drug |
| Nov 12, 2002 | Supplement 15Labeling · Standard review | Approved | None posted |
| Nov 12, 2002 | Supplement 9Labeling | Approved | None posted |
| Nov 12, 2002 | Supplement 8Labeling | Approved | None posted |
| Aug 26, 1997 | Supplement 16Manufacturing · Priority review | Approved | None posted |
| Apr 13, 1994 | Supplement 14Labeling · Standard review | Approved | None posted |
| Sep 7, 1993 | Supplement 13Labeling · Standard review | Approved | None posted |
| Dec 17, 1992 | Supplement 12Labeling | Approved | None posted |
| Jul 6, 1992 | Supplement 11Labeling | Approved | None posted |
| Apr 2, 1987 | Supplement 10Manufacturing · Priority review | Approved | None posted |
| Aug 27, 1980 | Supplement 7Manufacturing · Priority review | Approved | None posted |
| Feb 26, 1979 | Supplement 6 | Approved | None posted |
| Jan 25, 1978 | Supplement 5Labeling | Approved | None posted |
| Feb 21, 1955 | Original applicationNew molecular entity · Priority review | 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
