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Generated: November 21, 2018

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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 eleven drug master file entries for this compound. Twenty-seven 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
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:RXDosage:CAPSULE;ORALStrengthEQ 10MG BASE
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 25MG BASE
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 75MG BASE
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Expired US Patents for NDA 018013

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

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