← FDA DRUG APPROVALS

FDA NDA · NDA018013

PAMELOR

nortriptyline hydrochloride

Sponsor: SPECGX LLC

APPLICATION
NDA018013
TYPE
NDA
ORIGINAL APPROVAL
1977-08-01
LATEST ACTION
2019-04-09
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

PAMELOR · ReferenceDiscontinued
NORTRIPTYLINE HYDROCHLORIDE EQ 75MG BASE · CAPSULE · ORAL
PAMELOR · ReferenceDiscontinued
NORTRIPTYLINE HYDROCHLORIDE EQ 10MG BASE · CAPSULE · ORAL
PAMELOR · ReferenceDiscontinued
NORTRIPTYLINE HYDROCHLORIDE EQ 50MG BASE · CAPSULE · ORAL
PAMELOR · ReferenceDiscontinued
NORTRIPTYLINE HYDROCHLORIDE EQ 25MG BASE · CAPSULE · ORAL

Approval history

2019-04-09Labeling · Supplement 64 · standard — Label ↗AP
2014-07-28Labeling · Supplement 63 · standard — Letter ↗AP
2014-07-10Labeling · Supplement 62 · 901 required — Label ↗AP
2012-10-26Labeling · Supplement 61 · standard — Letter ↗AP
2007-07-13Labeling · Supplement 58 · standard — Letter ↗AP
2005-01-12Labeling · Supplement 56 · standard — Label ↗AP
2004-12-06Manufacturing (CMC) · Supplement 55 · standardAP
2001-07-31Labeling · Supplement 53 · standard — Review ↗AP
2001-06-07Manufacturing (CMC) · Supplement 54 · standardAP
2000-04-27Manufacturing (CMC) · Supplement 52 · standardAP
1999-04-28Manufacturing (CMC) · Supplement 50 · standardAP
1999-04-15Manufacturing (CMC) · Supplement 51 · standardAP
1995-12-07Manufacturing (CMC) · Supplement 48 · standardAP
1995-09-18Manufacturing (CMC) · Supplement 47 · standardAP
1994-07-07Manufacturing (CMC) · Supplement 44 · standardAP
1994-04-15Manufacturing (CMC) · Supplement 43 · standardAP
1994-04-01Manufacturing (CMC) · Supplement 42 · standardAP
1993-10-06Labeling · Supplement 41 · standardAP
1993-08-26Labeling · Supplement 30AP
1993-08-17Manufacturing (CMC) · Supplement 38 · standardAP
1993-07-23Manufacturing (CMC) · Supplement 34 · standardAP
1993-07-23Manufacturing (CMC) · Supplement 39 · standardAP
1993-06-16Manufacturing (CMC) · Supplement 36 · standardAP
1993-06-16Manufacturing (CMC) · Supplement 37 · standardAP
1993-06-10Manufacturing (CMC) · Supplement 35 · standardAP
1992-03-12Manufacturing (CMC) · Supplement 32 · standardAP
1992-01-21Manufacturing (CMC) · Supplement 33 · standardAP
1991-08-02Manufacturing (CMC) · Supplement 31 · standardAP
1991-03-13Labeling · Supplement 29AP
1990-03-26Manufacturing (CMC) · Supplement 26 · standardAP
1990-01-16Manufacturing (CMC) · Supplement 20 · standardAP
1989-11-07Manufacturing (CMC) · Supplement 23 · standardAP
1988-11-07Manufacturing (CMC) · Supplement 21 · standardAP
1986-08-25Manufacturing (CMC) · Supplement 19 · standardAP
1985-06-27Manufacturing (CMC) · Supplement 15 · standardAP
1985-06-11Labeling · Supplement 16AP
1984-12-11Manufacturing (CMC) · Supplement 14 · standardAP
1984-05-01Labeling · Supplement 12AP
1982-06-02Manufacturing (CMC) · Supplement 10 · standardAP
1982-03-25Manufacturing (CMC) · Supplement 9 · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →