ANDA 40167, held by Perrigo. Doxylamine Succinate.
As of Nov 15, 2026, ANDA 40167 (Doxylamine Succinate), held by Perrigo, was first approved by FDA on Sep 18, 1996, with 13 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 18, 1996 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Doxylamine Succinate25MG · tablet;oral | Doxylamine Succinate | OTC |
| Apr 4, 2024 | Supplement 52Manufacturing | Approved | None posted |
| Feb 20, 2024 | Supplement 51Manufacturing | Approved | None posted |
| Oct 6, 2023 | Supplement 50Labeling · Standard review | Approved | None posted |
| Mar 6, 2015 | Supplement 43Labeling · Standard review | Approved | None posted |
| Oct 9, 2014 | Supplement 41Manufacturing | Approved | None posted |
| Jun 2, 2009 | Supplement 33Labeling | Approved | None posted |
| Jul 14, 2008 | Supplement 31Labeling | Approved | None posted |
| Sep 10, 2002 | Supplement 6Labeling | Approved | None posted |
| Oct 4, 2001 | Supplement 4Manufacturing | Approved | None posted |
| Oct 4, 2001 | Supplement 5Manufacturing | Approved | None posted |
| Jan 21, 1999 | Supplement 3Manufacturing | Approved | None posted |
| Feb 10, 1998 | Supplement 1Manufacturing | Approved | None posted |
| Feb 10, 1998 | Supplement 2Manufacturing | Approved | None posted |
| Sep 18, 1996 | Original application | 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
