NDA 18506, held by Schering. Azatadine Maleate; Pseudoephedrine Sulfate.
As of Nov 14, 2026, NDA 18506 (Trinalin), held by Schering, was first approved by FDA on Mar 23, 1982, with 20 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 23, 1982 | Original applicationNew combination · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Trinalin1MG;120MG · tablet, extended release;oral | Azatadine Maleate; Pseudoephedrine Sulfate | Discontinued |
| Dec 12, 2002 | Supplement 25Labeling · Standard review | Approved | |
| Nov 1, 2002 | Supplement 24Labeling · Standard review | Approved | |
| Nov 1, 2000 | Supplement 22Manufacturing · Standard review | Approved | |
| Sep 13, 2000 | Supplement 18Manufacturing · Standard review | Approved | |
| Aug 4, 2000 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Apr 25, 2000 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| May 18, 1998 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Jul 1, 1992 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Apr 20, 1992 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Jan 24, 1989 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Jan 24, 1989 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Apr 6, 1988 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| May 1, 1987 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Jul 8, 1986 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Jul 2, 1985 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Mar 4, 1985 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Feb 6, 1985 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Sep 18, 1984 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Aug 31, 1984 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Feb 24, 1984 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Mar 23, 1982 | Original applicationNew combination · 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
