Nortriptyline Hydrochloride

Relieves symptoms of depression. ANDA 74132, held by Teva. Nortriptyline Hydrochloride.

As of Nov 15, 2026, ANDA 74132 (Nortriptyline Hydrochloride), held by Teva, was first approved by FDA on Mar 27, 1995, with 19 approved supplements and 0 published complete response letters.

First approved: Mar 27, 1995
Supplements approved: 19
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Nortriptyline hydrochloride capsules are indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below

Date	Submission	Status	Documents
Mar 27, 1995	Original application	Approved	None posted

Products

4 strengths and forms


Nortriptyline HydrochlorideEQ 10MG BASE · capsule;oral	Nortriptyline Hydrochloride	Rx
Nortriptyline HydrochlorideEQ 25MG BASE · capsule;oral	Nortriptyline Hydrochloride	Rx
Nortriptyline HydrochlorideEQ 50MG BASE · capsule;oral	Nortriptyline Hydrochloride	Rx
Nortriptyline HydrochlorideEQ 75MG BASE · capsule;oral	Nortriptyline Hydrochloride	Rx

All 20 submissions, including labeling and manufacturing supplements


Apr 24, 2024	Supplement 31Labeling · Standard review	Approved	None posted
Apr 15, 2020	Supplement 28Labeling · Standard review	Approved	None posted
Apr 13, 2015	Supplement 26Labeling · Standard review	Approved	None posted
Apr 13, 2015	Supplement 24Labeling · Standard review	Approved	None posted
Dec 30, 2010	Supplement 22Labeling	Approved	None posted
Oct 19, 2007	Supplement 20Labeling	Approved	None posted
Jul 2, 2007	Supplement 19Labeling	Approved	None posted
Apr 11, 2007	Supplement 18Labeling	Approved	None posted
Jul 20, 2005	Supplement 15Labeling	Approved	None posted
Feb 20, 2002	Supplement 10Labeling	Approved	None posted
Aug 30, 2001	Supplement 9Manufacturing	Approved	None posted
Jul 7, 2000	Supplement 8Manufacturing	Approved	None posted
Jul 21, 1998	Supplement 7Manufacturing	Approved	None posted
Jul 21, 1998	Supplement 6Manufacturing	Approved	None posted
Mar 27, 1997	Supplement 5Labeling	Approved	None posted
Jan 25, 1996	Supplement 4Manufacturing	Approved	None posted
Jan 25, 1996	Supplement 3Manufacturing	Approved	None posted
Jan 25, 1996	Supplement 2Manufacturing	Approved	None posted
Sep 26, 1995	Supplement 1Labeling	Approved	None posted
Mar 27, 1995	Original application	Approved	None posted

Identifiers

Application: ANDA 74132
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceutical Industries

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