Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208030

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FERRIPROX (DEFERIPRONE)
100MG/ML
Marketing Status: Prescription

Active Ingredient: DEFERIPRONE
Proprietary Name: FERRIPROX
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 100MG/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208030
Product Number: 001
Approval Date: Sep 9, 2015
Applicant Holder Full Name: CHIESI USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

FERRIPROX (DEFERIPRONE)
80MG/ML
Marketing Status: Discontinued

Active Ingredient: DEFERIPRONE
Proprietary Name: FERRIPROX
Dosage Form; Route of Administration: SOLUTION; ORAL
Strength: 80MG/ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N208030
Product Number: 002
Approval Date: Apr 20, 2018
Applicant Holder Full Name: CHIESI USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information