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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 202036

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NDA 202036 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 202036

Tradename:	VENLAFAXINE HYDROCHLORIDE
Applicant:	Yaopharma Co Ltd
Ingredient:	venlafaxine hydrochloride
Patents:	0

Pharmacology for NDA: 202036

Mechanism of Action	Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors

Medical Subject Heading (MeSH) Categories for 202036

Antidepressive Agents, Second-Generation
Serotonin and Noradrenaline Reuptake Inhibitors

Suppliers and Packaging for NDA: 202036

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VENLAFAXINE HYDROCHLORIDE	venlafaxine hydrochloride	TABLET;ORAL	202036	ANDA	Yaopharma Co., Ltd.	50771-001	50771-001-02	100 TABLET in 1 BOTTLE, PLASTIC (50771-001-02)
VENLAFAXINE HYDROCHLORIDE	venlafaxine hydrochloride	TABLET;ORAL	202036	ANDA	Yaopharma Co., Ltd.	50771-002	50771-002-02	100 TABLET in 1 BOTTLE, PLASTIC (50771-002-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 25MG BASE
Approval Date:	May 28, 2015	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 37.5MG BASE
Approval Date:	May 28, 2015	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 50MG BASE
Approval Date:	May 28, 2015	TE:	AB	RLD:	No

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