Relieves symptoms of depression. ANDA 75520, held by Taro. Nortriptyline Hydrochloride.
As of Nov 15, 2026, ANDA 75520 (Nortriptyline Hydrochloride), held by Taro, was first approved by FDA on May 8, 2000, with 6 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Nortriptyline hydrochloride 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 |
|---|---|---|---|
| May 8, 2000 | Original application | Approved |
| Nortriptyline HydrochlorideEQ 50MG BASE · capsule;oral | Nortriptyline Hydrochloride | Rx |
| Nortriptyline HydrochlorideEQ 75MG BASE · capsule;oral | Nortriptyline Hydrochloride | Rx |
| Nortriptyline HydrochlorideEQ 25MG BASE · capsule;oral | Nortriptyline Hydrochloride | Rx |
| Nortriptyline HydrochlorideEQ 10MG BASE · capsule;oral | Nortriptyline Hydrochloride | Rx |
| Apr 16, 2020 | Supplement 8Labeling · Standard review | Approved | None posted |
| Apr 13, 2015 | Supplement 4Labeling · Standard review | Approved | None posted |
| Apr 13, 2015 | Supplement 6Labeling · Standard review | Approved | None posted |
| Feb 19, 2009 | Supplement 3Labeling | Approved | None posted |
| Aug 3, 2007 | Supplement 2Labeling | Approved | None posted |
| Jul 20, 2005 | Supplement 1Labeling | Approved | None posted |
| May 8, 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
