Pamelor

NDA 18012, held by Specgx LLC. Nortriptyline Hydrochloride.

As of Nov 14, 2026, NDA 18012 (Pamelor), held by Specgx LLC, was first approved by FDA on Aug 1, 1977, with 19 approved supplements and 0 published complete response letters.

First approved: Aug 1, 1977
Review: Standard
Supplements approved: 19
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 20 submissions below


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

1 strengths and forms

Product	Active ingredient	Marketing
PamelorEQ 10MG BASE/5ML · solution;oral	Nortriptyline Hydrochloride	Discontinued

All 20 submissions, including labeling and manufacturing supplements


Jul 28, 2014	Supplement 31Labeling · Standard review	Approved	Letter Label
Jul 10, 2014	Supplement 30Labeling	Approved	Letter Label
Oct 26, 2012	Supplement 29Labeling · Standard review	Approved	Letter Label
Jul 13, 2007	Supplement 27Labeling · Standard review	Approved	Letter Label
Jan 12, 2005	Supplement 26Labeling · Standard review	Approved	Letter Label
Jul 31, 2001	Supplement 24Labeling · Standard review	Approved	Review Label
Dec 23, 1999	Supplement 23Manufacturing · Standard review	Approved	None posted
Mar 29, 1994	Supplement 19Manufacturing · Standard review	Approved	None posted
Mar 26, 1990	Supplement 15Manufacturing · Standard review	Approved	None posted
Apr 13, 1989	Supplement 12Manufacturing · Standard review	Approved	None posted
Aug 25, 1986	Supplement 11Manufacturing · Standard review	Approved	None posted
Jun 11, 1985	Supplement 10Labeling	Approved	None posted
May 1, 1984	Supplement 8Labeling	Approved	None posted
Jul 7, 1982	Supplement 7Manufacturing · Standard review	Approved	None posted
Feb 18, 1982	Supplement 2Manufacturing · Standard review	Approved	None posted
Mar 25, 1981	Supplement 6Manufacturing · Standard review	Approved	None posted
Jan 31, 1980	Supplement 4Manufacturing · Standard review	Approved	None posted
Jun 15, 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 18012
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