Nortriptyline Hydrochloride

ANDA 74054, held by Ani Pharms. Nortriptyline Hydrochloride.

As of Nov 15, 2026, ANDA 74054 (Nortriptyline Hydrochloride), held by Ani Pharms, was first approved by FDA on Dec 31, 1992, with 14 approved supplements and 0 published complete response letters.

First approved: Dec 31, 1992
Supplements approved: 14
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Dec 31, 1992	Original application	Approved	None posted

Products

4 strengths and forms


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

All 15 submissions, including labeling and manufacturing supplements


Feb 8, 2002	Supplement 15Labeling	Approved	None posted
Nov 6, 2001	Supplement 14Manufacturing	Approved	None posted
Aug 3, 2001	Supplement 13Manufacturing	Approved	None posted
Jun 9, 1999	Supplement 10Manufacturing	Approved	None posted
May 5, 1999	Supplement 11Manufacturing	Approved	None posted
Apr 5, 1999	Supplement 8Labeling	Approved	None posted
Apr 5, 1999	Supplement 7Manufacturing	Approved	None posted
Mar 12, 1999	Supplement 9Manufacturing	Approved	None posted
Dec 12, 1997	Supplement 5Manufacturing	Approved	None posted
Sep 29, 1997	Supplement 6Labeling	Approved	None posted
Jul 31, 1996	Supplement 4Manufacturing	Approved	None posted
Apr 5, 1995	Supplement 3Labeling	Approved	None posted
Sep 22, 1993	Supplement 1Manufacturing	Approved	None posted
Aug 24, 1993	Supplement 2Labeling	Approved	None posted
Dec 31, 1992	Original application	Approved	None posted

Identifiers

Application: ANDA 74054
Drugs@FDA: Overview at FDA
Company: ANI Pharmaceuticals

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