Norpramin

Treats depression. NDA 14399, held by Validus Pharms. Desipramine Hydrochloride.

As of Nov 13, 2026, NDA 14399 (Norpramin), held by Validus Pharms, was first approved by FDA on Nov 20, 1964, with 45 approved supplements and 0 published complete response letters.

First approved: Nov 20, 1964
Review: Standard
Supplements approved: 45
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE NORPRAMIN is indicated for the treatment of depression.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 46 submissions below


Jun 25, 1976	Supplement 20Efficacy (new indication or use)	Approved	None posted
Nov 20, 1964	Original applicationNew active ingredient · Standard review	Approved	None posted

Products

6 strengths and forms


Norpramin25MG · tablet;oral	Desipramine Hydrochloride	DiscontinuedReference drug
Norpramin50MG · tablet;oral	Desipramine Hydrochloride	DiscontinuedReference drug
Norpramin75MG · tablet;oral	Desipramine Hydrochloride	DiscontinuedReference drug
Norpramin100MG · tablet;oral	Desipramine Hydrochloride	DiscontinuedReference drug
Norpramin150MG · tablet;oral	Desipramine Hydrochloride	DiscontinuedReference drug
Norpramin10MG · tablet;oral	Desipramine Hydrochloride	DiscontinuedReference drug

All 46 submissions, including labeling and manufacturing supplements


Jun 24, 2025	Supplement 72Labeling	Approved	Label Letter
Nov 9, 2018	Supplement 71Labeling · Standard review	Approved	Letter Label
Aug 7, 2014	Supplement 68Manufacturing · Standard review	Approved	None posted
Jul 2, 2014	Supplement 69Labeling	Approved	Letter Label
Nov 19, 2012	Supplement 66Labeling	Approved	Label Letter
Nov 19, 2012	Supplement 67Labeling · Standard review	Approved	Medication Guide Label Letter
Oct 26, 2009	Supplement 65Labeling	Approved	Letter Label
Jul 30, 2007	Supplement 64Labeling · Standard review	Approved	Letter Label
Apr 11, 2006	Supplement 63Labeling · Standard review	Approved	Letter Label
Jan 12, 2005	Supplement 62Labeling · Standard review	Approved	Letter Label
May 23, 2000	Supplement 55Labeling	Approved	None posted
May 23, 2000	Supplement 58Labeling · Standard review	Approved	None posted
May 23, 2000	Supplement 60Labeling · Standard review	Approved	None posted
May 23, 2000	Supplement 61Labeling · Standard review	Approved	None posted
Sep 3, 1992	Supplement 56Manufacturing · Standard review	Approved	None posted
Dec 11, 1991	Supplement 52Labeling	Approved	None posted
Dec 11, 1991	Supplement 53Labeling	Approved	None posted
Dec 10, 1990	Supplement 49Labeling	Approved	None posted
Dec 10, 1990	Supplement 42Labeling	Approved	None posted
Apr 25, 1990	Supplement 50Manufacturing · Standard review	Approved	None posted
Jun 19, 1989	Supplement 51Manufacturing · Standard review	Approved	None posted
Mar 21, 1989	Supplement 48Manufacturing · Standard review	Approved	None posted
Nov 15, 1988	Supplement 45Manufacturing · Standard review	Approved	None posted
Jun 20, 1988	Supplement 46Manufacturing · Standard review	Approved	None posted
Mar 30, 1988	Supplement 47Manufacturing · Standard review	Approved	None posted
Apr 3, 1987	Supplement 44Manufacturing · Standard review	Approved	None posted
Jun 24, 1986	Supplement 43Manufacturing · Standard review	Approved	None posted
Apr 29, 1985	Supplement 40Labeling	Approved	None posted
Jun 22, 1982	Supplement 37Manufacturing · Standard review	Approved	None posted
Jun 22, 1982	Supplement 38Manufacturing · Standard review	Approved	None posted
Feb 11, 1982	Supplement 33Manufacturing · Standard review	Approved	None posted
Feb 1, 1982	Supplement 32Manufacturing · Standard review	Approved	None posted
Feb 1, 1982	Supplement 34Manufacturing · Standard review	Approved	None posted
Feb 1, 1982	Supplement 35Manufacturing · Standard review	Approved	None posted
Feb 1, 1982	Supplement 36Manufacturing · Standard review	Approved	None posted
Aug 18, 1980	Supplement 30Labeling	Approved	None posted
Jul 28, 1980	Supplement 31Labeling	Approved	None posted
Feb 14, 1980	Supplement 29Manufacturing · Standard review	Approved	None posted
Mar 1, 1977	Supplement 27Labeling	Approved	None posted
Jun 25, 1976	Supplement 20Efficacy (new indication or use)	Approved	None posted
May 28, 1976	Supplement 22Labeling	Approved	None posted
Oct 6, 1975	Supplement 23Labeling	Approved	None posted
Apr 15, 1975	Supplement 21Manufacturing · Standard review	Approved	None posted
Apr 4, 1975	Supplement 19Manufacturing · Standard review	Approved	None posted
Jul 2, 1974	Supplement 18Manufacturing · Standard review	Approved	None posted
Nov 20, 1964	Original applicationNew active ingredient · Standard review	Approved	None posted

Identifiers

Application: NDA 14399
Drugs@FDA: Overview at FDA
Company: Validus Pharmaceuticals

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