Protriptyline Hydrochloride

Treats symptoms of mental depression. ANDA 90462, held by Sigmapharm Labs LLC. Protriptyline Hydrochloride.

As of Nov 14, 2026, ANDA 90462 (Protriptyline Hydrochloride), held by Sigmapharm Labs LLC, was first approved by FDA on May 3, 2010, with 1 approved supplement and 0 published complete response letters.

First approved: May 3, 2010
Supplements approved: 1
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 Its activating properties make it particularly suitable for withdrawn and anergic patients.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 2 submissions below

Date	Submission	Status	Documents
May 3, 2010	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 2 submissions, including labeling and manufacturing supplements


Jul 17, 2014	Supplement 3Labeling · Standard review	Approved	None posted
May 3, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 90462
Drugs@FDA: Overview at FDA
Company: SigmaPharm Laboratories LLC

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