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Serving leading biopharmaceutical companies globally:

Julphar
Mallinckrodt
Deloitte
UBS
Chubb
Moodys
Citi
US Army
Queensland Health
Express Scripts

Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079017

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NDA 079017 describes ATOMOXETINE HYDROCHLORIDE, which is a drug marketed by Apotex Inc, Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Teva Pharms Usa, and Zydus Pharms Usa Inc, and is included in five NDAs. It is available from seven suppliers. Additional details are available on the ATOMOXETINE HYDROCHLORIDE profile page.

The generic ingredient in ATOMOXETINE HYDROCHLORIDE is atomoxetine hydrochloride. There are fourteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the atomoxetine hydrochloride profile page.

Summary for 079017

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Central Nervous System Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 079017

Medical Subject Heading (MeSH) Categories for 079017

Suppliers and Packaging for NDA: 079017

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ATOMOXETINE HYDROCHLORIDE atomoxetine hydrochloride CAPSULE;ORAL 079017 ANDA Cadila Healthcare Limited 65841-606 65841-606-02 2000 CAPSULE in 1 BOTTLE (65841-606-02)
ATOMOXETINE HYDROCHLORIDE atomoxetine hydrochloride CAPSULE;ORAL 079017 ANDA Cadila Healthcare Limited 65841-606 65841-606-14 60 CAPSULE in 1 BOTTLE (65841-606-14)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength18MG
Approval Date:Sep 17, 2010TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength25MG
Approval Date:Sep 17, 2010TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength40MG
Approval Date:Sep 17, 2010TE:RLD:No


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Serving leading biopharmaceutical companies globally:

Healthtrust
Merck
Covington
Boehringer Ingelheim
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McKesson
QuintilesIMS
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