NDA 16675, held by Merck. Dexamethasone Acetate.
As of Nov 13, 2026, NDA 16675 (Decadron-La), held by Merck, was first approved by FDA on Sep 6, 1973, with 10 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 6, 1973 | Original applicationNew active ingredient · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Decadron-LaEQ 8MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Dexamethasone Acetate | DiscontinuedReference drug |
| Mar 1, 1996 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Aug 27, 1993 | Supplement 28Labeling · Standard review | Approved | None posted |
| Dec 11, 1989 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| May 16, 1989 | Supplement 19Labeling · Standard review | Approved | None posted |
| Mar 8, 1985 | Supplement 20Labeling · Standard review | Approved | None posted |
| Feb 21, 1983 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Mar 4, 1982 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Dec 21, 1981 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Dec 3, 1981 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Aug 8, 1979 | Supplement 12Labeling · Standard review | Approved | None posted |
| Sep 6, 1973 | Original applicationNew active ingredient · Standard 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
