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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 214609

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NDA 214609 describes VENLAFAXINE HYDROCHLORIDE, which is a drug marketed by Alembic, Anchen Pharms, Annora Pharma, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Granules, Inventia Hlthcare, Macleods Pharms Ltd, Medicap Labs, Nostrum Pharms Llc, Orbion Pharms, Pharmobedient, Sciegen Pharms, Teva, Torrent, Valeant Pharms North, Yichang Humanwell, Zydus Pharms Usa Inc, Abon Pharms Llc, Adaptis, Ajanta Pharma Ltd, Alkem Labs Ltd, Ascent Pharms Inc, Cadila Pharms Ltd, Dexcel, Mpp Pharma, Osmotica Pharm Us, Somerset Theraps Llc, 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-seven NDAs. It is available from sixty 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-two suppliers are listed for this compound. Additional details are available on the venlafaxine hydrochloride profile page.

Summary for 214609

Tradename:	VENLAFAXINE HYDROCHLORIDE
Applicant:	Somerset Theraps Llc
Ingredient:	venlafaxine hydrochloride
Patents:	0

Pharmacology for NDA: 214609

Mechanism of Action	Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors

Medical Subject Heading (MeSH) Categories for 214609

Antidepressive Agents, Second-Generation
Serotonin and Noradrenaline Reuptake Inhibitors

Suppliers and Packaging for NDA: 214609

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VENLAFAXINE HYDROCHLORIDE	venlafaxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	214609	ANDA	Dr. Reddy's Laboratories Inc.	43598-943	43598-943-30	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43598-943-30)
VENLAFAXINE HYDROCHLORIDE	venlafaxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	214609	ANDA	Dr. Reddy's Laboratories Inc.	43598-943	43598-943-90	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (43598-943-90)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 150MG BASE
Approval Date:	Jun 30, 2021	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 225MG BASE
Approval Date:	Jun 30, 2021	TE:	AB	RLD:	No

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