Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
AstraZeneca
Express Scripts
Baxter
Johnson and Johnson
McKesson
Mallinckrodt
Cantor Fitzgerald
Medtronic

Generated: April 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079017

« Back to Dashboard

NDA 079017 describes ATOMOXETINE HYDROCHLORIDE, which is a drug marketed by Apotex Inc, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Teva Pharms Usa, and Zydus Pharms Usa Inc, and is included in six NDAs. It is available from eight 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:ATOMOXETINE HYDROCHLORIDE
Applicant:Zydus Pharms Usa Inc
Ingredient:atomoxetine hydrochloride
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 N 65841-606-10
ATOMOXETINE HYDROCHLORIDE atomoxetine hydrochloride CAPSULE;ORAL 079017 ANDA Cadila Healthcare Limited 65841-606 N 65841-606-14

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

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Daiichi Sankyo
Johnson and Johnson
Fish and Richardson
Mallinckrodt
Merck
Deloitte
Fuji
McKinsey

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.