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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

Apopharma Inc
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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