Perphenazine And Amitriptyline Hydrochloride

ANDA 72134, held by Watson Labs. Amitriptyline Hydrochloride; Perphenazine.

As of Nov 15, 2026, ANDA 72134 (Perphenazine And Amitriptyline Hydrochloride), held by Watson Labs, was first approved by FDA on Feb 15, 1989, with 3 approved supplements and 0 published complete response letters.

First approved: Feb 15, 1989
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Feb 15, 1989	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 4 submissions, including labeling and manufacturing supplements


Apr 11, 1996	Supplement 5Labeling	Approved	None posted
Nov 4, 1993	Supplement 4Labeling	Approved	None posted
May 31, 1989	Supplement 1Labeling	Approved	None posted
Feb 15, 1989	Original application	Approved	None posted

Identifiers

Application: ANDA 72134
Drugs@FDA: Overview at FDA
Company: Watson 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