NDA 17980, held by Wyeth Ayerst. Mazindol.
As of Nov 13, 2026, NDA 17980 (Mazanor), held by Wyeth Ayerst, was first approved by FDA on Aug 28, 1980, with 10 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 28, 1980 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 6, 1995 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Oct 6, 1995 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Jun 27, 1991 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Feb 16, 1990 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Jun 8, 1987 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Dec 13, 1985 | Supplement 5Labeling · Standard review | Approved | None posted |
| Sep 15, 1982 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Feb 2, 1982 | Supplement 3Labeling · Standard review | Approved | None posted |
| Sep 8, 1981 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Feb 11, 1981 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Aug 28, 1980 | Original applicationNew formulation or manufacturer · 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
