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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 076468


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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
Formulation / Manufacturing:see details
Pharmacology for NDA: 076468
Mechanism of ActionPhosphodiesterase 3 Inhibitors
Physiological EffectDecreased 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:RXDosage:CAPSULE;ORALStrengthEQ 0.5MG BASE
Approval Date:Apr 18, 2005TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 1MG BASE
Approval Date:Apr 18, 2005TE:ABRLD:No

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