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

Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
QuintilesIMS
Cerilliant
Baxter
Fuji
Julphar
Teva
Argus Health
Federal Trade Commission

Generated: June 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202045

« Back to Dashboard

NDA 202045 describes DULOXETINE HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Ajanta Pharma Ltd, Alembic Pharms Ltd, Alkem Labs Ltd, Anchen Pharms, Apotex Inc, Aurobindo Pharma Ltd, Breckenridge Pharm, Dr Reddys Labs Ltd, Hetero Labs Ltd Iii, Inventia Hlthcare, Lupin Ltd, Macleods Pharms Ltd, Prinston Inc, Sun Pharma Global, Teva Pharms Usa, Torrent Pharms Ltd, Zydus Hlthcare, and Zydus Pharms Usa Inc, and is included in nineteen NDAs. It is available from forty-seven suppliers. Additional details are available on the DULOXETINE HYDROCHLORIDE profile page.

The generic ingredient in DULOXETINE HYDROCHLORIDE is duloxetine hydrochloride. There are forty-one drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the duloxetine hydrochloride profile page.
Summary for 202045
Tradename:DULOXETINE HYDROCHLORIDE
Applicant:Apotex Inc
Ingredient:duloxetine hydrochloride
Patents:0
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details
Pharmacology for NDA: 202045
Suppliers and Packaging for NDA: 202045
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DULOXETINE HYDROCHLORIDE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 202045 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-8034 N 0615-8034-39
DULOXETINE HYDROCHLORIDE duloxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 202045 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-8035 N 0615-8035-39

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 20MG BASE
Approval Date:Jun 11, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 30MG BASE
Approval Date:Jun 11, 2014TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 60MG BASE
Approval Date:Jun 11, 2014TE:ABRLD: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:

Argus Health
AstraZeneca
Julphar
Covington
Daiichi Sankyo
Harvard Business School
US Army
Accenture
Teva

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.