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Last Updated: July 20, 2024

Details for New Drug Application (NDA): 020333

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NDA 020333 describes AGRYLIN, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from one supplier. Additional details are available on the AGRYLIN profile page.

The generic ingredient in AGRYLIN 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 020333
Applicant:Takeda Pharms Usa
Ingredient:anagrelide hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 020333
Mechanism of ActionPhosphodiesterase 3 Inhibitors
Physiological EffectDecreased Platelet Production
Suppliers and Packaging for NDA: 020333
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AGRYLIN anagrelide hydrochloride CAPSULE;ORAL 020333 NDA Takeda Pharmaceuticals America, Inc. 54092-063 54092-063-01 100 CAPSULE in 1 BOTTLE (54092-063-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 0.5MG BASE
Approval Date:Mar 14, 1997TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Mar 14, 1997TE:RLD:Yes

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