Details for New Drug Application (NDA): 021992

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NDA 021992 describes PRISTIQ, which is a drug marketed by Pf Prism Cv and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the PRISTIQ profile page.

The generic ingredient in PRISTIQ is desvenlafaxine succinate. There are sixteen drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the desvenlafaxine succinate profile page.

Summary for 021992

Tradename:	PRISTIQ
Applicant:	Pf Prism Cv
Ingredient:	desvenlafaxine succinate
Patents:	1

Pharmacology for NDA: 021992

Mechanism of Action	Cytochrome P450 2D6 Inhibitors Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors

Medical Subject Heading (MeSH) Categories for 021992

Antidepressive Agents
Serotonin and Noradrenaline Reuptake Inhibitors

Suppliers and Packaging for NDA: 021992

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PRISTIQ	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	021992	NDA	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	0008-1210	0008-1210-30	30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0008-1210-30)
PRISTIQ	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	021992	NDA	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	0008-1211	0008-1211-01	90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0008-1211-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 50MG BASE
Approval Date:	Feb 29, 2008	TE:	AB	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Jul 5, 2027	Product Flag?		Substance Flag?	Y	Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 100MG BASE
Approval Date:	Feb 29, 2008	TE:	AB	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Jul 5, 2027	Product Flag?		Substance Flag?	Y	Delist Request?

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 25MG BASE
Approval Date:	Aug 20, 2014	TE:	AB	RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Jul 5, 2027	Product Flag?		Substance Flag?	Y	Delist Request?

Expired US Patents for NDA 021992

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pf Prism Cv	PRISTIQ	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	021992-002	Feb 29, 2008	⤷ Sign Up	⤷ Sign Up
Pf Prism Cv	PRISTIQ	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	021992-003	Aug 20, 2014	⤷ Sign Up	⤷ Sign Up
Pf Prism Cv	PRISTIQ	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	021992-002	Feb 29, 2008	⤷ Sign Up	⤷ Sign Up
Pf Prism Cv	PRISTIQ	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	021992-001	Feb 29, 2008	⤷ Sign Up	⤷ Sign Up
Pf Prism Cv	PRISTIQ	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	021992-001	Feb 29, 2008	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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