You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 21, 2024

Details for New Drug Application (NDA): 078421

✉ Email this page to a colleague

« Back to Dashboard

NDA 078421 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-four 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-seven 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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.