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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 022104

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NDA 022104 describes VENLAFAXINE HYDROCHLORIDE, which is a drug marketed by Alembic, Anchen Pharms, Annora Pharma, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Granules, Intellipharmaceutics, Inventia Hlthcare, Macleods Pharms Ltd, Norvium Bioscience, Nostrum Pharms Llc, Orbion Pharms, Teva, Torrent, Valeant Pharms North, Wockhardt Bio Ag, Yichang Humanwell, Zydus Pharms Usa Inc, Ajanta Pharma Ltd, Alkem Labs Ltd, Appco, Ascent Pharms Inc, Cadila Pharms Ltd, Dexcel, Nostrum Labs Inc, Osmotica Pharm Us, Sun Pharm, Swiss Pharm, Unique, Zydus Pharms, Alembic Pharms Ltd, Amneal Pharms, Aurobindo Pharma, Chartwell Rx, Heritage, Pliva Hrvatska Doo, Prinston Inc, Sun Pharm Inds Inc, Yaopharma Co Ltd, and Zydus Pharms Usa, and is included in forty-five NDAs. It is available from sixty-three suppliers. Additional details are available on the VENLAFAXINE HYDROCHLORIDE profile page.

The generic ingredient in VENLAFAXINE HYDROCHLORIDE is venlafaxine hydrochloride. There are seventy-one drug master file entries for this compound. Sixty-six suppliers are listed for this compound. Additional details are available on the venlafaxine hydrochloride profile page.

Summary for 022104

Tradename:	VENLAFAXINE HYDROCHLORIDE
Applicant:	Osmotica Pharm Us
Ingredient:	venlafaxine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 022104

Antidepressive Agents, Second-Generation
Serotonin and Noradrenaline Reuptake Inhibitors

Suppliers and Packaging for NDA: 022104

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VENLAFAXINE HYDROCHLORIDE	venlafaxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022104	NDA AUTHORIZED GENERIC	Trigen Laboratories, LLC	13811-712	13811-712-30	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (13811-712-30)
VENLAFAXINE HYDROCHLORIDE	venlafaxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022104	NDA AUTHORIZED GENERIC	Trigen Laboratories, LLC	13811-712	13811-712-90	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (13811-712-90)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 37.5MG BASE
Approval Date:	May 20, 2008	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 75MG BASE
Approval Date:	May 20, 2008	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 150MG BASE
Approval Date:	May 20, 2008	TE:	AB	RLD:	Yes

Expired US Patents for NDA 022104

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Osmotica Pharm Us	VENLAFAXINE HYDROCHLORIDE	venlafaxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022104-002	May 20, 2008	⤷ Sign Up	⤷ Sign Up
Osmotica Pharm Us	VENLAFAXINE HYDROCHLORIDE	venlafaxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022104-001	May 20, 2008	⤷ Sign Up	⤷ Sign Up
Osmotica Pharm Us	VENLAFAXINE HYDROCHLORIDE	venlafaxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022104-004	May 20, 2008	⤷ Sign Up	⤷ Sign Up
Osmotica Pharm Us	VENLAFAXINE HYDROCHLORIDE	venlafaxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022104-002	May 20, 2008	⤷ Sign Up	⤷ Sign Up
Osmotica Pharm Us	VENLAFAXINE HYDROCHLORIDE	venlafaxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022104-003	May 20, 2008	⤷ Sign Up	⤷ Sign Up
Osmotica Pharm Us	VENLAFAXINE HYDROCHLORIDE	venlafaxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022104-001	May 20, 2008	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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