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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 090728


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NDA 090728 describes DULOXETINE HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Ajanta Pharma Ltd, Alembic, Alkem Labs Ltd, Apotex, Aurobindo Pharma Ltd, Breckenridge, Cspc Ouyi, Graviti Pharms, Hetero Labs Ltd Iii, Inventia, Lupin Ltd, Macleods Pharms Ltd, Ph Health, Prinston Inc, Qingdao Baheal Pharm, Sun Pharm, Sunshine, Teva Pharms Usa, Torrent, Yaopharma Co Ltd, Zydus Hlthcare, and Zydus Pharms, and is included in twenty-three NDAs. It is available from forty-six suppliers. Additional details are available on the DULOXETINE HYDROCHLORIDE profile page.

The generic ingredient in DULOXETINE HYDROCHLORIDE is duloxetine hydrochloride. There are forty-two drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the duloxetine hydrochloride profile page.
Summary for 090728
Tradename:DULOXETINE HYDROCHLORIDE
Applicant:Zydus Pharms
Ingredient:duloxetine hydrochloride
Patents:0
Medical Subject Heading (MeSH) Categories for 090728
Analgesics
Antidepressive Agents
Dopamine Agents
Serotonin and Noradrenaline Reuptake Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 20MG BASE
Approval Date:Jan 8, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 30MG BASE
Approval Date:Jan 8, 2014TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 60MG BASE
Approval Date:Jan 8, 2014TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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