Nortriptyline Hydrochloride

Relieves symptoms of depression. ANDA 73556, held by Dr Reddys Labs SA. Nortriptyline Hydrochloride.

As of Nov 15, 2026, ANDA 73556 (Nortriptyline Hydrochloride), held by Dr Reddys Labs SA, was first approved by FDA on Mar 30, 1992, with 20 approved supplements and 0 published complete response letters.

First approved: Mar 30, 1992
Supplements approved: 20
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Nortriptyline hydrochloride, USP is 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 21 submissions below

Date	Submission	Status	Documents
Mar 30, 1992	Original application	Approved	None posted

Products

4 strengths and forms


Nortriptyline HydrochlorideEQ 75MG BASE · capsule;oral	Nortriptyline Hydrochloride	Rx
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

All 21 submissions, including labeling and manufacturing supplements


Feb 21, 2020	Supplement 55Labeling · Standard review	Approved	None posted
Jul 15, 2015	Supplement 52Labeling · Standard review	Approved	None posted
Jul 15, 2015	Supplement 50Labeling · Standard review	Approved	None posted
Feb 20, 2008	Supplement 34Labeling	Approved	None posted
Jul 3, 2007	Supplement 32Labeling	Approved	None posted
Apr 12, 2007	Supplement 29Labeling	Approved	None posted
Nov 1, 2006	Supplement 24Labeling	Approved	None posted
Jul 26, 2005	Supplement 22Labeling	Approved	None posted
Jan 4, 2002	Supplement 16Labeling	Approved	None posted
Apr 25, 2001	Supplement 15Manufacturing	Approved	None posted
Aug 26, 1998	Supplement 13Manufacturing	Approved	None posted
Aug 26, 1998	Supplement 12Manufacturing	Approved	None posted
Feb 7, 1997	Supplement 11Labeling	Approved	None posted
Dec 5, 1995	Supplement 10Labeling	Approved	None posted
Jul 11, 1995	Supplement 8Manufacturing	Approved	None posted
May 25, 1995	Supplement 9Manufacturing	Approved	None posted
May 25, 1995	Supplement 7Manufacturing	Approved	None posted
Feb 16, 1995	Supplement 6Manufacturing	Approved	None posted
Feb 16, 1995	Supplement 5Manufacturing	Approved	None posted
Aug 31, 1993	Supplement 4Labeling	Approved	None posted
Mar 30, 1992	Original application	Approved	None posted

Identifiers

Application: ANDA 73556
Drugs@FDA: Overview at FDA
Company: Dr. Reddy's Laboratories

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