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Harvard Business School
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US Army
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Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 073554

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NDA 073554 describes NORTRIPTYLINE HYDROCHLORIDE, which is a drug marketed by Aurolife Pharma Llc, Idt Australia Ltd, Mayne Pharma, Mylan, Taro Pharm, Teva, Pharm Assoc, and Taro, and is included in twelve NDAs. It is available from thirty-three 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. Thirty-four suppliers are listed for this compound. Additional details are available on the nortriptyline hydrochloride profile page.

Summary for 073554

Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details

Pharmacology for NDA: 073554

Medical Subject Heading (MeSH) Categories for 073554

Suppliers and Packaging for NDA: 073554

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NORTRIPTYLINE HYDROCHLORIDE nortriptyline hydrochloride CAPSULE;ORAL 073554 ANDA Watson Laboratories, Inc. 0591-5787 0591-5787-01 100 CAPSULE in 1 BOTTLE, PLASTIC (0591-5787-01)
NORTRIPTYLINE HYDROCHLORIDE nortriptyline hydrochloride CAPSULE;ORAL 073554 ANDA Watson Laboratories, Inc. 0591-5787 0591-5787-10 1000 CAPSULE in 1 BOTTLE, PLASTIC (0591-5787-10)

Summary for product number 001

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

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Serving leading biopharmaceutical companies globally:

Argus Health
Fish and Richardson
Queensland Health
Express Scripts
US Army
US Department of Justice

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