Details for New Drug Application (NDA): 076468

NDA 076468 describes ANAGRELIDE HYDROCHLORIDE, which is a drug marketed by Barr, Chartwell Rx, Impax Labs, Ivax Sub Teva Pharms, Natco Pharma Usa, Rising, Roxane, Torrent, and Watson Labs, and is included in nine NDAs. It is available from three suppliers. Additional details are available on the ANAGRELIDE HYDROCHLORIDE profile page.

The generic ingredient in ANAGRELIDE HYDROCHLORIDE is anagrelide hydrochloride. There are eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the anagrelide hydrochloride profile page.

Summary for 076468

Tradename:	ANAGRELIDE HYDROCHLORIDE
Applicant:	Ivax Sub Teva Pharms
Ingredient:	anagrelide hydrochloride
Patents:	0

Pharmacology for NDA: 076468

Mechanism of Action	Phosphodiesterase 3 Inhibitors
Physiological Effect	Decreased Platelet Production

Suppliers and Packaging for NDA: 076468

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ANAGRELIDE HYDROCHLORIDE	anagrelide hydrochloride	CAPSULE;ORAL	076468	ANDA	Teva Pharmaceuticals USA, Inc.	0172-5240	0172-5240-60	100 CAPSULE in 1 BOTTLE (0172-5240-60)
ANAGRELIDE HYDROCHLORIDE	anagrelide hydrochloride	CAPSULE;ORAL	076468	ANDA	Teva Pharmaceuticals USA, Inc.	0172-5241	0172-5241-60	100 CAPSULE in 1 BOTTLE (0172-5241-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 0.5MG BASE
Approval Date:	Apr 18, 2005	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 1MG BASE
Approval Date:	Apr 18, 2005	TE:	AB	RLD:	No

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