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Generated: August 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020333

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NDA 020333 describes AGRYLIN, which is a drug marketed by Shire Llc 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. Six suppliers are listed for this compound. Additional details are available on the anagrelide hydrochloride profile page.

Summary for NDA: 020333

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 020333

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 Shire US Manufacturing Inc. 54092-063 54092-063-01 100 CAPSULE in 1 BOTTLE (54092-063-01)

Summary for product number 001

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

Summary 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1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Mar 14, 1997TE:RLD:Yes


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Serving 500+ biopharmaceutical companies globally:

Johnson and Johnson
AstraZeneca
Queensland Health
Teva
Fuji
McKesson
Medtronic
Argus Health
Daiichi Sankyo
Fish and Richardson

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