Last Updated: May 3, 2026

Details for New Drug Application (NDA): 219131


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NDA 219131 describes DULOXETINE HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Adaptis, Ajanta Pharma Ltd, Alembic, Alkem Labs Ltd, Almatica, Apotex, Aurobindo Pharma Ltd, Breckenridge, Cspc Ouyi, 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-four NDAs. It is available from forty-four 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-five suppliers are listed for this compound. Additional details are available on the duloxetine hydrochloride profile page.
Summary for 219131
Tradename:DULOXETINE HYDROCHLORIDE
Applicant:Almatica
Ingredient:duloxetine hydrochloride
Patents:0
Medical Subject Heading (MeSH) Categories for 219131
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 80MG BASE
Approval Date:Feb 27, 2026TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 90MG BASE
Approval Date:Feb 27, 2026TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED REL PELLETS;ORALStrengthEQ 120MG BASE
Approval Date:Feb 27, 2026TE:RLD:Yes

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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