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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 076683

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NDA 076683 describes ANAGRELIDE HYDROCHLORIDE, which is a drug marketed by Barr Labs, Chartwell Rx, Cipla, Impax Labs, Novitium Pharma, 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 076683

Tradename:	ANAGRELIDE HYDROCHLORIDE
Applicant:	Chartwell Rx
Ingredient:	anagrelide hydrochloride
Patents:	0

Pharmacology for NDA: 076683

Mechanism of Action	Phosphodiesterase 3 Inhibitors
Physiological Effect	Decreased Platelet Production

Suppliers and Packaging for NDA: 076683

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ANAGRELIDE HYDROCHLORIDE	anagrelide hydrochloride	CAPSULE;ORAL	076683	ANDA	Chartwell RX, LLC	62135-312	62135-312-12	120 CAPSULE in 1 BOTTLE (62135-312-12)
ANAGRELIDE HYDROCHLORIDE	anagrelide hydrochloride	CAPSULE;ORAL	076683	ANDA	Chartwell RX, LLC	62135-313	62135-313-60	60 CAPSULE in 1 BOTTLE (62135-313-60)

Profile for product number 001

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

Profile for product number 002

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

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