Details for New Drug Application (NDA): 020699

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NDA 020699 describes EFFEXOR XR, which is a drug marketed by Upjohn and is included in one NDA. It is available from two suppliers. Additional details are available on the EFFEXOR XR profile page.

The generic ingredient in EFFEXOR XR 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 020699

Tradename:	EFFEXOR XR
Applicant:	Upjohn
Ingredient:	venlafaxine hydrochloride
Patents:	0

Pharmacology for NDA: 020699

Mechanism of Action	Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors

Medical Subject Heading (MeSH) Categories for 020699

Antidepressive Agents, Second-Generation
Serotonin and Noradrenaline Reuptake Inhibitors

Suppliers and Packaging for NDA: 020699

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EFFEXOR XR	venlafaxine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020699	NDA	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	0008-0836	0008-0836-21	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0008-0836-21)
EFFEXOR XR	venlafaxine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020699	NDA	Viatris Specialty LLC	58151-125	58151-125-77	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (58151-125-77)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	EQ 37.5MG BASE
Approval Date:	Oct 20, 1997	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	EQ 75MG BASE
Approval Date:	Oct 20, 1997	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Oct 20, 1997	TE:		RLD:	Yes

Expired US Patents for NDA 020699

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Upjohn	EFFEXOR XR	venlafaxine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020699-002	Oct 20, 1997	4,535,186*PED	⤷ Get Started Free
Upjohn	EFFEXOR XR	venlafaxine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020699-004	Oct 20, 1997	6,310,101	⤷ Get Started Free
Upjohn	EFFEXOR XR	venlafaxine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020699-001	Oct 20, 1997	4,535,186*PED	⤷ Get Started Free
Upjohn	EFFEXOR XR	venlafaxine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020699-003	Oct 20, 1997	6,444,708*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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