NDA 11418, held by Wyeth Ayerst. Brompheniramine Maleate.
As of Nov 14, 2026, NDA 11418 (Dimetane-Ten), held by Wyeth Ayerst, was first approved by FDA on Sep 29, 1958, with 13 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 29, 1958 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dimetane-Ten10MG/ML · injectable;injection | Brompheniramine Maleate | Discontinued |
| Jun 3, 1992 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Jun 16, 1988 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Aug 13, 1986 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Jun 6, 1984 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Dec 18, 1981 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Jun 6, 1981 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Nov 21, 1980 | Supplement 17Labeling · Standard review | Approved | None posted |
| Feb 1, 1980 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Jun 26, 1979 | Supplement 15Labeling · Standard review | Approved | None posted |
| Jun 26, 1979 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Dec 7, 1978 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| May 15, 1978 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Aug 26, 1977 | Supplement 11Labeling · Standard review | Approved | None posted |
| Sep 29, 1958 | Original applicationNew dosage form · 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
