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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo

Generated: February 25, 2018

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. Thirteen suppliers are listed for this compound. Additional details are available on the atomoxetine hydrochloride profile page.
Summary for 079017
Applicant:Zydus Pharms Usa Inc
Ingredient:atomoxetine hydrochloride
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 N 65841-606-14
ATOMOXETINE HYDROCHLORIDE atomoxetine hydrochloride CAPSULE;ORAL 079017 ANDA Cadila Healthcare Limited 65841-606 N 65841-606-16

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

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

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
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