ANDA 40564, held by Lnk. Doxylamine Succinate.
As of Nov 15, 2026, ANDA 40564 (Doxylamine Succinate), held by Lnk, was first approved by FDA on Aug 27, 2004, with 0 approved supplements and 0 published complete response letters.
Use helps to reduce difficulty in falling asleep
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 27, 2004 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Doxylamine Succinate25MG · tablet;oral | Doxylamine Succinate | OTC |
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
