Treats insomnia characterized. NDA 22036, held by Currax. Doxepin Hydrochloride.
As of Nov 14, 2026, NDA 22036 (Silenor), held by Currax, was first approved by FDA on Mar 17, 2010, with 4 approved supplements and 0 published complete response letters.
1. INDICATIONS AND USAGE SILENOR is indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. The clinical trials performed in support of efficacy were up to 3 months in duration. SILENOR (doxepin) tablets are
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 17, 2010 | Original applicationNew dosage form · Standard review | Approved |
| SilenorEQ 3MG BASE · tablet;oral | Doxepin Hydrochloride | RxReference drug |
| SilenorEQ 6MG BASE · tablet;oral | Doxepin Hydrochloride | RxReference drug |
| Oct 29, 2020 | Supplement 6Labeling · Standard review | Approved | |
| Dec 22, 2016 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Aug 8, 2014 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Oct 30, 2011 | Supplement 1REMS | Approved | |
| Mar 17, 2010 | Original applicationNew dosage form · Standard review | Approved |
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
