Perphenazine And Amitriptyline Hydrochloride

ANDA 73010, held by Chartwell Rx. Amitriptyline Hydrochloride; Perphenazine.

As of Nov 15, 2026, ANDA 73010 (Perphenazine And Amitriptyline Hydrochloride), held by Chartwell Rx, was first approved by FDA on Oct 17, 1991, with 25 approved supplements and 0 published complete response letters.

First approved: Oct 17, 1991
Supplements approved: 25
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 26 submissions below

Date	Submission	Status	Documents
Oct 17, 1991	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Perphenazine And Amitriptyline Hydrochloride25MG;4MG · tablet;oral	Amitriptyline Hydrochloride; Perphenazine	Discontinued

All 26 submissions, including labeling and manufacturing supplements


Jun 24, 2025	Supplement 29Labeling · Standard review	Approved	None posted
Jan 22, 2025	Supplement 28Labeling · Standard review	Approved	None posted
Feb 23, 2017	Supplement 27Labeling · Standard review	Approved	None posted
Apr 25, 2016	Supplement 26Labeling · Standard review	Approved	None posted
Nov 3, 2015	Supplement 23Labeling	Approved	None posted
Jan 16, 2015	Supplement 25Labeling · Standard review	Approved	None posted
Jul 17, 2014	Supplement 24Labeling · Standard review	Approved	None posted
Apr 25, 2001	Supplement 22Labeling	Approved	None posted
Apr 12, 2001	Supplement 20Manufacturing	Approved	None posted
Feb 28, 2001	Supplement 21Labeling	Approved	None posted
Mar 21, 2000	Supplement 18Manufacturing	Approved	None posted
May 7, 1999	Supplement 17Manufacturing	Approved	None posted
Jun 16, 1998	Supplement 16Labeling	Approved	None posted
Jun 16, 1998	Supplement 14Manufacturing	Approved	None posted
Jun 16, 1998	Supplement 13Manufacturing	Approved	None posted
Jul 8, 1997	Supplement 11Manufacturing	Approved	None posted
Mar 26, 1997	Supplement 6Manufacturing	Approved	None posted
Mar 26, 1997	Supplement 5Manufacturing	Approved	None posted
Mar 26, 1997	Supplement 4Manufacturing	Approved	None posted
Mar 26, 1997	Supplement 3Manufacturing	Approved	None posted
Dec 31, 1996	Supplement 9Manufacturing	Approved	None posted
Dec 31, 1996	Supplement 8Manufacturing	Approved	None posted
Apr 29, 1996	Supplement 7Labeling	Approved	None posted
Aug 29, 1995	Supplement 2Labeling	Approved	None posted
Aug 31, 1993	Supplement 1Labeling	Approved	None posted
Oct 17, 1991	Original application	Approved	None posted

Identifiers

Application: ANDA 73010
Drugs@FDA: Overview at FDA
Company: Chartwell RX

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