Details for New Drug Application (NDA): 090783

NDA 090783 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, Endo Operations, Hetero Labs Ltd Iii, Inventia, Lupin Ltd, Macleods Pharms Ltd, Marksans Pharma, 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-nine 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. Fifty suppliers are listed for this compound. Additional details are available on the duloxetine hydrochloride profile page.

Summary for 090783

Tradename:	DULOXETINE HYDROCHLORIDE
Applicant:	Teva Pharms Usa
Ingredient:	duloxetine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 090783

Analgesics

Antidepressive Agents

Dopamine Agents

Serotonin and Noradrenaline Reuptake Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, DELAYED REL PELLETS;ORAL			Strength	EQ 20MG BASE
Approval Date:	Dec 11, 2013	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, DELAYED REL PELLETS;ORAL			Strength	EQ 30MG BASE
Approval Date:	Dec 11, 2013	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, DELAYED REL PELLETS;ORAL			Strength	EQ 60MG BASE
Approval Date:	Dec 11, 2013	TE:		RLD:	No

Complete Access Available with Subscription