Perphenazine And Amitriptyline Hydrochloride

ANDA 70337, held by Mylan. Amitriptyline Hydrochloride; Perphenazine.

As of Nov 15, 2026, ANDA 70337 (Perphenazine And Amitriptyline Hydrochloride), held by Mylan, was first approved by FDA on Nov 10, 1988, with 11 approved supplements and 0 published complete response letters.

First approved: Nov 10, 1988
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Nov 10, 1988	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Perphenazine And Amitriptyline Hydrochloride25MG;2MG · tablet; oral	Amitriptyline Hydrochloride; Perphenazine	Rx

All 12 submissions, including labeling and manufacturing supplements


May 7, 2002	Supplement 12Labeling	Approved	None posted
Feb 25, 1998	Supplement 11Manufacturing	Approved	None posted
Feb 5, 1998	Supplement 10Manufacturing	Approved	None posted
Feb 4, 1997	Supplement 9Manufacturing	Approved	None posted
Jun 28, 1995	Supplement 8Labeling	Approved	None posted
Oct 22, 1993	Supplement 5Manufacturing	Approved	None posted
Oct 5, 1993	Supplement 7Labeling	Approved	None posted
Oct 5, 1993	Supplement 3Manufacturing	Approved	None posted
Sep 1, 1993	Supplement 6Labeling	Approved	None posted
Jan 31, 1990	Supplement 2Manufacturing	Approved	None posted
May 1, 1989	Supplement 1Labeling	Approved	None posted
Nov 10, 1988	Original application	Approved	None posted

Identifiers

Application: ANDA 70337
Drugs@FDA: Overview at FDA
Company: Mylan

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