NDA 11664, held by Merck. Dexamethasone.
As of Nov 13, 2026, NDA 11664 (Decadron), held by Merck, was first approved by FDA on Oct 30, 1958, with 32 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 30, 1958 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Decadron0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Dexamethasone | DiscontinuedReference drug |
| Decadron0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Dexamethasone | DiscontinuedReference drug |
| Decadron1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Dexamethasone | DiscontinuedReference drug |
| Decadron0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Dexamethasone | DiscontinuedReference drug |
| Decadron4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Dexamethasone | DiscontinuedReference drug |
| Decadron6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Dexamethasone | DiscontinuedReference drug |
| May 8, 2019 | Supplement 64Labeling · Standard review | Approved | |
| Apr 23, 2018 | Supplement 65Labeling · Standard review | Approved | |
| Jul 29, 2016 | Supplement 63Labeling · Standard review | Approved | |
| May 17, 2004 | Supplement 62Labeling · Standard review | Approved | |
| Jun 25, 2002 | Supplement 60Manufacturing · Priority review | Approved | None posted |
| Feb 19, 1999 | Supplement 58Manufacturing · Priority review | Approved | None posted |
| May 14, 1998 | Supplement 55Manufacturing · Priority review | Approved | None posted |
| Feb 26, 1998 | Supplement 57Manufacturing · Priority review | Approved | None posted |
| Mar 1, 1996 | Supplement 53Manufacturing · Priority review | Approved | None posted |
| Aug 25, 1993 | Supplement 50Labeling · Standard review | Approved | None posted |
| May 16, 1989 | Supplement 44Labeling | Approved | None posted |
| May 3, 1988 | Supplement 47Manufacturing · Priority review | Approved | None posted |
| Nov 26, 1985 | Supplement 45Labeling | Approved | None posted |
| May 3, 1984 | Supplement 41Manufacturing · Priority review | Approved | None posted |
| May 11, 1983 | Supplement 43Manufacturing · Priority review | Approved | None posted |
| Mar 22, 1983 | Supplement 42Manufacturing · Priority review | Approved | None posted |
| Jul 30, 1982 | Supplement 36Labeling | Approved | None posted |
| Jul 30, 1982 | Supplement 21Manufacturing · Priority review | Approved | None posted |
| Feb 10, 1982 | Supplement 37Manufacturing · Priority review | Approved | None posted |
| Apr 1, 1981 | Supplement 38Labeling | Approved | None posted |
| Apr 23, 1980 | Supplement 35Manufacturing · Priority review | Approved | None posted |
| Feb 5, 1980 | Supplement 32Manufacturing · Priority review | Approved | None posted |
| Feb 4, 1980 | Supplement 34Labeling | Approved | None posted |
| Feb 4, 1980 | Supplement 33Labeling | Approved | None posted |
| Oct 26, 1979 | Supplement 26Manufacturing · Priority review | Approved | None posted |
| Sep 24, 1979 | Supplement 30Manufacturing · Priority review | Approved | None posted |
| Aug 15, 1979 | Supplement 31Labeling | Approved | None posted |
| Jul 26, 1979 | Supplement 29Labeling | Approved | None posted |
| Jul 26, 1979 | Supplement 28Labeling | Approved | None posted |
| Jul 26, 1979 | Supplement 27Labeling | Approved | None posted |
| Jul 26, 1979 | Supplement 24Labeling | Approved | None posted |
| Oct 11, 1978 | Supplement 25Manufacturing · Priority review | Approved | None posted |
| Oct 30, 1958 | 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
