NDA 10598, held by Sanofi Aventis US. Doxylamine Succinate; Pyridoxine Hydrochloride.
As of Nov 14, 2026, NDA 10598 (Bendectin), held by Sanofi Aventis US, was first approved by FDA on Jul 30, 1956, with 12 approved supplements and 0 published complete response letters.
| Nov 9, 1976 | Supplement 2Efficacy (new indication or use) | Approved | None posted |
| Jul 30, 1956 | Original applicationNew combination · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Bendectin10MG;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, extended release;oral | Doxylamine Succinate; Pyridoxine Hydrochloride | Discontinued |
| Dec 9, 1982 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Sep 7, 1982 | Supplement 13Labeling | Approved | None posted |
| Jun 16, 1982 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Oct 22, 1981 | Supplement 10Labeling | Approved | None posted |
| Oct 22, 1981 | Supplement 11Labeling | Approved | None posted |
| Jan 9, 1981 | Supplement 9Labeling | Approved | None posted |
| Nov 6, 1979 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Jul 25, 1979 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Nov 1, 1978 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Aug 1, 1978 | Supplement 5Labeling | Approved | None posted |
| Nov 9, 1976 | Supplement 2Efficacy (new indication or use) | Approved | None posted |
| Nov 9, 1976 | Supplement 3Labeling | Approved | None posted |
| Jul 30, 1956 | 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
