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Generated: May 26, 2017

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Details for New Drug Application (NDA): 021825

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NDA 021825 describes FERRIPROX, which is a drug marketed by Apopharma Inc and is included in two NDAs. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the FERRIPROX profile page.

The generic ingredient in FERRIPROX is deferiprone. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the deferiprone profile page.

Summary for NDA: 021825

Formulation / Manufacturing:see details

Pharmacology for NDA: 021825

Mechanism of ActionIron Chelating Activity

Suppliers and Packaging for NDA: 021825

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 021825 NDA ApoPharma USA, Inc. 52609-0006 52609-0006-1 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (52609-0006-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Oct 14, 2011TE:RLD:Yes
Patent:7,049,328Patent Expiration:Jun 28, 2021Product Flag?Substance Flag?Delist Request?
Regulatory Exclusivity Expiration:Oct 14, 2016
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Oct 14, 2018
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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