Relieves symptoms of depression. ANDA 217731, held by Rubicon Research. Nortriptyline Hydrochloride.
As of Nov 15, 2026, ANDA 217731 (Nortriptyline Hydrochloride), held by Rubicon Research, was first approved by FDA on Aug 15, 2023, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Nortriptyline hydrochloride oral solution is indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 15, 2023 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nortriptyline HydrochlorideEQ 10MG BASE/5ML · solution;oral | Nortriptyline Hydrochloride | Rx |
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
