Pamelor

Relieves symptoms of depression. NDA 18013, held by Specgx LLC. Nortriptyline Hydrochloride.

As of Nov 14, 2026, NDA 18013 (Pamelor), held by Specgx LLC, was first approved by FDA on Aug 1, 1977, with 47 approved supplements and 0 published complete response letters.

First approved: Aug 1, 1977
Review: Standard
Supplements approved: 47
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Pamelor (nortriptyline HCl) is indicated for the relief of symptoms of depression. Endogenous depressions are more likely to be alleviated than are other depressive states.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 48 submissions below


Feb 18, 1982	Supplement 2Efficacy (new indication or use)	Approved	None posted
Jun 29, 1978	Supplement 1Efficacy (new indication or use)	Approved	None posted
Aug 1, 1977	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

4 strengths and forms


PamelorEQ 10MG BASE · capsule;oral	Nortriptyline Hydrochloride	DiscontinuedReference drug
PamelorEQ 25MG BASE · capsule;oral	Nortriptyline Hydrochloride	DiscontinuedReference drug
PamelorEQ 75MG BASE · capsule;oral	Nortriptyline Hydrochloride	DiscontinuedReference drug
PamelorEQ 50MG BASE · capsule;oral	Nortriptyline Hydrochloride	DiscontinuedReference drug

All 48 submissions, including labeling and manufacturing supplements


Apr 9, 2019	Supplement 64Labeling · Standard review	Approved	Label Medication Guide Letter
Jul 28, 2014	Supplement 63Labeling · Standard review	Approved	Letter Label
Jul 10, 2014	Supplement 62Labeling	Approved	Label Letter
Oct 26, 2012	Supplement 61Labeling · Standard review	Approved	Letter Label
Jul 13, 2007	Supplement 58Labeling · Standard review	Approved	Letter Label
Jan 12, 2005	Supplement 56Labeling · Standard review	Approved	Label Letter
Dec 6, 2004	Supplement 55Manufacturing · Standard review	Approved	None posted
Jul 31, 2001	Supplement 53Labeling · Standard review	Approved	Review
Jun 7, 2001	Supplement 54Manufacturing · Standard review	Approved	None posted
Apr 27, 2000	Supplement 52Manufacturing · Standard review	Approved	None posted
Apr 28, 1999	Supplement 50Manufacturing · Standard review	Approved	None posted
Apr 15, 1999	Supplement 51Manufacturing · Standard review	Approved	None posted
Dec 7, 1995	Supplement 48Manufacturing · Standard review	Approved	None posted
Sep 18, 1995	Supplement 47Manufacturing · Standard review	Approved	None posted
Jul 7, 1994	Supplement 44Manufacturing · Standard review	Approved	None posted
Apr 15, 1994	Supplement 43Manufacturing · Standard review	Approved	None posted
Apr 1, 1994	Supplement 42Manufacturing · Standard review	Approved	None posted
Oct 6, 1993	Supplement 41Labeling · Standard review	Approved	None posted
Aug 26, 1993	Supplement 30Labeling	Approved	None posted
Aug 17, 1993	Supplement 38Manufacturing · Standard review	Approved	None posted
Jul 23, 1993	Supplement 39Manufacturing · Standard review	Approved	None posted
Jul 23, 1993	Supplement 34Manufacturing · Standard review	Approved	None posted
Jun 16, 1993	Supplement 37Manufacturing · Standard review	Approved	None posted
Jun 16, 1993	Supplement 36Manufacturing · Standard review	Approved	None posted
Jun 10, 1993	Supplement 35Manufacturing · Standard review	Approved	None posted
Mar 12, 1992	Supplement 32Manufacturing · Standard review	Approved	None posted
Jan 21, 1992	Supplement 33Manufacturing · Standard review	Approved	None posted
Aug 2, 1991	Supplement 31Manufacturing · Standard review	Approved	None posted
Mar 13, 1991	Supplement 29Labeling	Approved	None posted
Mar 26, 1990	Supplement 26Manufacturing · Standard review	Approved	None posted
Jan 16, 1990	Supplement 20Manufacturing · Standard review	Approved	None posted
Nov 7, 1989	Supplement 23Manufacturing · Standard review	Approved	None posted
Nov 7, 1988	Supplement 21Manufacturing · Standard review	Approved	None posted
Aug 25, 1986	Supplement 19Manufacturing · Standard review	Approved	None posted
Jun 27, 1985	Supplement 15Manufacturing · Standard review	Approved	None posted
Jun 11, 1985	Supplement 16Labeling	Approved	None posted
Dec 11, 1984	Supplement 14Manufacturing · Standard review	Approved	None posted
May 1, 1984	Supplement 12Labeling	Approved	None posted
Jun 2, 1982	Supplement 10Manufacturing · Standard review	Approved	None posted
Mar 25, 1982	Supplement 9Manufacturing · Standard review	Approved	None posted
Feb 18, 1982	Supplement 2Efficacy (new indication or use)	Approved	None posted
Jul 24, 1981	Supplement 7Manufacturing · Standard review	Approved	None posted
Jun 26, 1981	Supplement 8Manufacturing · Standard review	Approved	None posted
Nov 20, 1979	Supplement 5Labeling	Approved	None posted
Sep 17, 1979	Supplement 4Manufacturing · Standard review	Approved	None posted
Jun 14, 1979	Supplement 3Manufacturing · Standard review	Approved	None posted
Jun 29, 1978	Supplement 1Efficacy (new indication or use)	Approved	None posted
Aug 1, 1977	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 18013
Drugs@FDA: Overview at FDA
Company: SpecGx

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