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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 078421

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NDA 078421 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 Inc, Teva, Torrent, Valeant Pharms North, Yichang Humanwell, Zydus Pharms Usa Inc, Abon Pharms Llc, Adaptis, Ajanta Pharma Ltd, Alkem Labs Ltd, Appco, Ascent Pharms Inc, Cadila Pharms Ltd, Dexcel, Mpp Pharma, 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-seven 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-five suppliers are listed for this compound. Additional details are available on the venlafaxine hydrochloride profile page.

Summary for 078421

Tradename:	VENLAFAXINE HYDROCHLORIDE
Applicant:	Dr Reddys Labs Ltd
Ingredient:	venlafaxine hydrochloride
Patents:	0

Pharmacology for NDA: 078421

Mechanism of Action	Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors

Medical Subject Heading (MeSH) Categories for 078421

Antidepressive Agents, Second-Generation
Serotonin and Noradrenaline Reuptake Inhibitors

Suppliers and Packaging for NDA: 078421

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VENLAFAXINE HYDROCHLORIDE	venlafaxine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	078421	ANDA	Dr.Reddys Laboratories Inc	43598-001	43598-001-10	1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43598-001-10)
VENLAFAXINE HYDROCHLORIDE	venlafaxine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	078421	ANDA	Dr.Reddys Laboratories Inc	43598-001	43598-001-30	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43598-001-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	EQ 37.5MG BASE
Approval Date:	May 6, 2011	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	EQ 75MG BASE
Approval Date:	May 6, 2011	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	EQ 150MG BASE
Approval Date:	May 6, 2011	TE:	AB	RLD:	No

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