Vivactil

ANDA 73644, held by Chartwell Rx. Protriptyline Hydrochloride.

As of Nov 14, 2026, ANDA 73644 (Vivactil), held by Chartwell Rx, was first approved by FDA on Aug 24, 1995, with 9 approved supplements and 0 published complete response letters.

First approved: Aug 24, 1995
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Aug 24, 1995	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Vivactil5MG · tablet;oral	Protriptyline Hydrochloride	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Jul 17, 2014	Supplement 23Labeling · Standard review	Approved	Label
Jun 25, 2007	Supplement 17Labeling	Approved	None posted
Apr 5, 2006	Supplement 10Labeling	Approved	None posted
Jul 18, 2002	Supplement 6Manufacturing	Approved	None posted
Aug 3, 2001	Supplement 5Manufacturing	Approved	None posted
Apr 3, 2001	Supplement 4Manufacturing	Approved	None posted
Sep 12, 2000	Supplement 1Manufacturing	Approved	None posted
Jul 24, 2000	Supplement 3Labeling	Approved	None posted
Jul 7, 2000	Supplement 2Manufacturing	Approved	None posted
Aug 24, 1995	Original application	Approved	None posted

Identifiers

Application: ANDA 73644
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