Pertofrane

NDA 13621, held by Sanofi Aventis US. Desipramine Hydrochloride.

As of Nov 14, 2026, NDA 13621 (Pertofrane), held by Sanofi Aventis US, was first approved by FDA on Apr 10, 1968, with 4 approved supplements and 0 published complete response letters.

First approved: Apr 10, 1968
Review: Standard
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Apr 10, 1968	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

2 strengths and forms


Pertofrane25MG · capsule;oral	Desipramine Hydrochloride	Discontinued
Pertofrane50MG · capsule;oral	Desipramine Hydrochloride	Discontinued

All 5 submissions, including labeling and manufacturing supplements


Jul 30, 1985	Supplement 28Labeling	Approved	None posted
May 1, 1984	Supplement 27Labeling	Approved	None posted
Aug 16, 1977	Supplement 23Labeling	Approved	None posted
Jul 13, 1977	Supplement 25Labeling	Approved	None posted
Apr 10, 1968	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 13621
Drugs@FDA: Overview at FDA
Company: sanofi-aventis US

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