Relieves symptoms of depression. ANDA 75606, held by Pharm Assoc. Nortriptyline Hydrochloride.
As of Nov 15, 2026, ANDA 75606 (Nortriptyline Hydrochloride), held by Pharm Assoc, was first approved by FDA on Aug 23, 2000, with 5 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 23, 2000 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nortriptyline HydrochlorideEQ 10MG BASE/5ML · solution;oral | Nortriptyline Hydrochloride | Rx |
| Apr 5, 2023 | Supplement 9Labeling · Standard review | Approved | None posted |
| Apr 26, 2010 | Supplement 6Labeling | Approved | None posted |
| May 7, 2009 | Supplement 5Labeling | Approved | None posted |
| Oct 6, 2005 | Supplement 2Labeling | Approved | None posted |
| Aug 22, 2001 | Supplement 1Labeling | Approved | None posted |
| Aug 23, 2000 | Original application | 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
