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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Argus Health
Harvard Business School
Johnson and Johnson
Teva
US Army
UBS
Merck
Julphar

Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 073556

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NDA 073556 describes NORTRIPTYLINE HYDROCHLORIDE, which is a drug marketed by Ani Pharms Inc, Aurolife Pharma Llc, Mayne Pharma, Mylan, Taro Pharm, Teva, Pharm Assoc, and Taro, and is included in nine NDAs. It is available from twenty-six suppliers. Additional details are available on the NORTRIPTYLINE HYDROCHLORIDE profile page.

The generic ingredient in NORTRIPTYLINE HYDROCHLORIDE 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 073556
Tradename:NORTRIPTYLINE HYDROCHLORIDE
Applicant:Mayne Pharma
Ingredient:nortriptyline hydrochloride
Patents:0
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details
Pharmacology for NDA: 073556
Medical Subject Heading (MeSH) Categories for 073556
Suppliers and Packaging for NDA: 073556
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NORTRIPTYLINE HYDROCHLORIDE nortriptyline hydrochloride CAPSULE;ORAL 073556 ANDA Watson Laboratories, Inc. 0591-5789 N 0591-5789-01
NORTRIPTYLINE HYDROCHLORIDE nortriptyline hydrochloride CAPSULE;ORAL 073556 ANDA Rebel Distributors Corp 21695-600 E 21695-600-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 75MG BASE
Approval Date:Mar 30, 1992TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 10MG BASE
Approval Date:Mar 30, 1992TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 25MG BASE
Approval Date:Mar 30, 1992TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Express Scripts
Healthtrust
McKesson
QuintilesIMS
Daiichi Sankyo
Cipla
Merck
Queensland Health

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