Details for New Drug Application (NDA): 204082

NDA 204082 describes DESVENLAFAXINE SUCCINATE, which is a drug marketed by Actavis Labs Fl, Alembic, Hikma, Intellipharmaceutics, Lupin Ltd, Norvium Bioscience, Rubicon, Yichang Humanwell, and Zydus Pharms, and is included in ten NDAs. It is available from twenty suppliers. Additional details are available on the DESVENLAFAXINE SUCCINATE profile page.

The generic ingredient in DESVENLAFAXINE SUCCINATE 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 204082

Tradename:	DESVENLAFAXINE SUCCINATE
Applicant:	Hikma
Ingredient:	desvenlafaxine succinate
Patents:	0

Pharmacology for NDA: 204082

Mechanism of Action

Cytochrome P450 2D6 Inhibitors Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors

Medical Subject Heading (MeSH) Categories for 204082

Antidepressive Agents

Serotonin and Noradrenaline Reuptake Inhibitors

Suppliers and Packaging for NDA: 204082

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DESVENLAFAXINE SUCCINATE	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	204082	ANDA	Hikma Pharmaceuticals USA Inc.	0054-0400	0054-0400-13	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0054-0400-13)
DESVENLAFAXINE SUCCINATE	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	204082	ANDA	Hikma Pharmaceuticals USA Inc.	0054-0400	0054-0400-22	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0054-0400-22)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 50MG BASE
Approval Date:	Feb 16, 2016	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 25MG BASE
Approval Date:	Aug 28, 2017	TE:	AB	RLD:	No

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