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Last Updated: March 30, 2023

Details for New Drug Application (NDA): 020649

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NDA 020649 describes EDEX, which is a drug marketed by Auxilium Pharms Llc and is included in one NDA. It is available from one supplier. Additional details are available on the EDEX profile page.

The generic ingredient in EDEX is alprostadil. There are seven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the alprostadil profile page.

Summary for 020649

Tradename:	EDEX
Applicant:	Auxilium Pharms Llc
Ingredient:	alprostadil
Patents:	0

Pharmacology for NDA: 020649

Mechanism of Action	Prostaglandin Receptor Agonists
Physiological Effect	Genitourinary Arterial Vasodilation Venous Vasodilation

Medical Subject Heading (MeSH) Categories for 020649

Platelet Aggregation Inhibitors
Urological Agents
Vasodilator Agents

Suppliers and Packaging for NDA: 020649

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
EDEX	alprostadil	INJECTABLE;INJECTION	020649	NDA	Endo Pharmaceuticals Inc.	52244-010	52244-010-02	2 BLISTER PACK in 1 CARTON (52244-010-02) / 1 CARTRIDGE in 1 BLISTER PACK / 1 mL in 1 CARTRIDGE
EDEX	alprostadil	INJECTABLE;INJECTION	020649	NDA	Endo Pharmaceuticals Inc.	52244-010	52244-010-06	6 BLISTER PACK in 1 CARTON (52244-010-06) / 1 CARTRIDGE in 1 BLISTER PACK / 1 mL in 1 CARTRIDGE

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	0.005MG/VIAL
Approval Date:	Jun 12, 1997	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	0.01MG/VIAL
Approval Date:	Jun 12, 1997	TE:	AP	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	0.02MG/VIAL
Approval Date:	Jun 12, 1997	TE:	AP	RLD:	Yes

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