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Last Updated: July 7, 2020

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Details for New Drug Application (NDA): 208030


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NDA 208030 describes FERRIPROX, which is a drug marketed by Chiesi and is included in three NDAs. It is available from two suppliers. 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. Three suppliers are listed for this compound. Additional details are available on the deferiprone profile page.
Summary for 208030
Tradename:FERRIPROX
Applicant:Chiesi
Ingredient:deferiprone
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 208030
Mechanism of ActionIron Chelating Activity
Suppliers and Packaging for NDA: 208030
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FERRIPROX deferiprone SOLUTION;ORAL 208030 NDA ApoPharma USA, Inc. 52609-4502 52609-4502-7 500 mL in 1 BOTTLE, PLASTIC (52609-4502-7)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength100MG/ML
Approval Date:Sep 9, 2015TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Jun 28, 2021Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING CHRONIC IRON OVERLOAD
Patent:  Start TrialPatent Expiration:Oct 29, 2029Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF TREATING CHRONIC IRON OVERLOAD

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength80MG/ML
Approval Date:Apr 20, 2018TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Jun 28, 2021Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING CHRONIC IRON OVERLOAD

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
AstraZeneca
Merck
Boehringer Ingelheim
Moodys
Dow

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