Protriptyline Hydrochloride

Treats symptoms of mental depression. ANDA 202220, held by Epic Pharma LLC. Protriptyline Hydrochloride.

As of Nov 14, 2026, ANDA 202220 (Protriptyline Hydrochloride), held by Epic Pharma LLC, was first approved by FDA on Nov 19, 2012, with 3 approved supplements and 0 published complete response letters.

First approved: Nov 19, 2012
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Protriptyline hydrochloride tablets are indicated for the treatment of symptoms of mental depression in patients who are under close medical supervision. Its activating properties make it particularly suitable for withdrawn and anergic patients.

Full prescribing information on DailyMed ↗

Approvals and New Uses

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

Date	Submission	Status	Documents
Nov 19, 2012	Original application	Approved	None posted

Products

2 strengths and forms


Protriptyline Hydrochloride5MG · tablet;oral	Protriptyline Hydrochloride	Rx
Protriptyline Hydrochloride10MG · tablet;oral	Protriptyline Hydrochloride	Rx

All 4 submissions, including labeling and manufacturing supplements


Jan 7, 2026	Supplement 4Labeling · Standard review	Approved	None posted
Aug 11, 2020	Supplement 3Manufacturing	Approved	None posted
Jul 17, 2014	Supplement 1Labeling · Standard review	Approved	None posted
Nov 19, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 202220
Drugs@FDA: Overview at FDA
Company: Epic Pharma

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