Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 018013
Company: SPECGX LLC

• Medication Guide

• Other Important Information from FDA

Products on NDA 18013

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PAMELOR	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE;ORAL	Discontinued	None	Yes	No
PAMELOR	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE;ORAL	Discontinued	None	Yes	No
PAMELOR	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE;ORAL	Discontinued	None	Yes	No
PAMELOR	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE;ORAL	Discontinued	None	Yes	No

Labels for NDA 018013

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/09/2019	SUPPL-64	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/018013s064lbl.pdf
07/28/2014	SUPPL-63	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018013s063lbl.pdf
07/10/2014	SUPPL-62	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018013s062lbl.pdf
10/26/2012	SUPPL-61	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018012s029,018013s061lbl.pdf
07/13/2007	SUPPL-58	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018013s58lbl.pdf
01/12/2005	SUPPL-56	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/18012s026,18013s056lbl.pdf