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Last Updated: April 20, 2024

Details for New Drug Application (NDA): 018013

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NDA 018013 describes PAMELOR, which is a drug marketed by Specgx Llc and is included in two NDAs. It is available from one supplier. Additional details are available on the PAMELOR profile page.

The generic ingredient in PAMELOR is nortriptyline hydrochloride. There are twelve drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the nortriptyline hydrochloride profile page.

Summary for 018013

Tradename:	PAMELOR
Applicant:	Specgx Llc
Ingredient:	nortriptyline hydrochloride
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 018013

Medical Subject Heading (MeSH) Categories for 018013

Adrenergic Uptake Inhibitors
Antidepressive Agents, Tricyclic

Suppliers and Packaging for NDA: 018013

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PAMELOR	nortriptyline hydrochloride	CAPSULE;ORAL	018013	NDA	SpecGx LLC	0406-9910	0406-9910-03	30 CAPSULE in 1 BOTTLE (0406-9910-03)
PAMELOR	nortriptyline hydrochloride	CAPSULE;ORAL	018013	NDA	SpecGx LLC	0406-9911	0406-9911-03	30 CAPSULE in 1 BOTTLE (0406-9911-03)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 10MG BASE
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 25MG BASE
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 75MG BASE
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Expired US Patents for NDA 018013

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Specgx Llc	PAMELOR	nortriptyline hydrochloride	CAPSULE;ORAL	018013-004	Approved Prior to Jan 1, 1982	⤷ Try a Trial	⤷ Try a Trial
Specgx Llc	PAMELOR	nortriptyline hydrochloride	CAPSULE;ORAL	018013-003	Approved Prior to Jan 1, 1982	⤷ Try a Trial	⤷ Try a Trial
Specgx Llc	PAMELOR	nortriptyline hydrochloride	CAPSULE;ORAL	018013-001	Approved Prior to Jan 1, 1982	⤷ Try a Trial	⤷ Try a Trial
Specgx Llc	PAMELOR	nortriptyline hydrochloride	CAPSULE;ORAL	018013-002	Approved Prior to Jan 1, 1982	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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