← FDA DRUG APPROVALS

FDA NDA · NDA018012

PAMELOR

Sponsor: SPECGX LLC

APPLICATION
NDA018012
TYPE
NDA
ORIGINAL APPROVAL
1977-08-01
LATEST ACTION
2014-07-28
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

PAMELORDiscontinued
NORTRIPTYLINE HYDROCHLORIDE EQ 10MG BASE/5ML · SOLUTION · ORAL

Approval history

2014-07-28Labeling · Supplement 31 · standard — Letter ↗AP
2014-07-10Labeling · Supplement 30 · 901 required — Letter ↗AP
2012-10-26Labeling · Supplement 29 · standard — Letter ↗AP
2007-07-13Labeling · Supplement 27 · standard — Letter ↗AP
2005-01-12Labeling · Supplement 26 · standard — Letter ↗AP
2001-07-31Labeling · Supplement 24 · standard — Review ↗AP
1999-12-23Manufacturing (CMC) · Supplement 23 · standardAP
1994-03-29Manufacturing (CMC) · Supplement 19 · standardAP
1990-03-26Manufacturing (CMC) · Supplement 15 · standardAP
1989-04-13Manufacturing (CMC) · Supplement 12 · standardAP
1986-08-25Manufacturing (CMC) · Supplement 11 · standardAP
1985-06-11Labeling · Supplement 10AP
1984-05-01Labeling · Supplement 8AP
1982-07-07Manufacturing (CMC) · Supplement 7 · standardAP
1982-02-18Manufacturing (CMC) · Supplement 2 · standardAP
1981-03-25Manufacturing (CMC) · Supplement 6 · standardAP
1980-01-31Manufacturing (CMC) · Supplement 4 · standardAP
1979-06-15Manufacturing (CMC) · Supplement 3 · standardAP
1978-06-29Efficacy · Supplement 1AP
1977-08-01Type 5 - New Formulation or New Manufacturer · Original · standard — Medication Guide ↗AP
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 →