Details for New Drug Application (NDA): 204150

NDA 204150 describes DESVENLAFAXINE, which is a drug marketed by Alembic Pharms Ltd, Sun Pharm, Teva Pharms Usa, Actavis Labs Fl, Alembic, Hikma, Intellipharmaceutics, Lupin Ltd, Norvium Bioscience, Rubicon, Yichang Humanwell, and Zydus Pharms, and is included in thirteen NDAs. It is available from two suppliers. Additional details are available on the DESVENLAFAXINE profile page.

The generic ingredient in DESVENLAFAXINE 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 204150

Tradename:	DESVENLAFAXINE
Applicant:	Alembic Pharms Ltd
Ingredient:	desvenlafaxine
Patents:	0

Pharmacology for NDA: 204150

Mechanism of Action

Cytochrome P450 2D6 Inhibitors Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 204150

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DESVENLAFAXINE	desvenlafaxine	TABLET, EXTENDED RELEASE;ORAL	204150	NDA	Alembic Pharmaceuticals Limited	46708-152	46708-152-30	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-152-30)
DESVENLAFAXINE	desvenlafaxine	TABLET, EXTENDED RELEASE;ORAL	204150	NDA	Alembic Pharmaceuticals Limited	46708-152	46708-152-90	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-152-90)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	50MG
Approval Date:	Mar 4, 2013	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	100MG
Approval Date:	Mar 4, 2013	TE:		RLD:	Yes

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