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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 200430

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NDA 200430 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-five 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-eight suppliers are listed for this compound. Additional details are available on the venlafaxine hydrochloride profile page.

Summary for 200430

Tradename:	VENLAFAXINE HYDROCHLORIDE
Applicant:	Nostrum Pharms Llc
Ingredient:	venlafaxine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 200430

Antidepressive Agents, Second-Generation
Serotonin and Noradrenaline Reuptake Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	EQ 37.5MG BASE
Approval Date:	Apr 4, 2023	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	EQ 75MG BASE
Approval Date:	Apr 4, 2023	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	EQ 150MG BASE
Approval Date:	Apr 4, 2023	TE:		RLD:	No

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