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Last Updated: July 6, 2020

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Details for New Drug Application (NDA): 203389


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NDA 203389 describes PROCYSBI, which is a drug marketed by Horizon Pharma Usa and is included in two NDAs. There are sixteen patents protecting this drug. Additional details are available on the PROCYSBI profile page.

The generic ingredient in PROCYSBI is cysteamine bitartrate. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cysteamine bitartrate profile page.
Summary for 203389
Tradename:PROCYSBI
Applicant:Horizon Pharma Usa
Ingredient:cysteamine bitartrate
Patents:11
Formulation / Manufacturing:see details
Paragraph IV (Patent) Challenges for 203389
Tradename Dosage Ingredient NDA Submissiondate
PROCYSBI CAPSULE, DELAYED RELEASE;ORAL cysteamine bitartrate 203389 2020-05-11

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrengthEQ 25MG BASE
Approval Date:Apr 30, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 30, 2020
Regulatory Exclusivity Use:MANAGEMENT OF NEPHROPATHIC CYSTINOSIS IN ADULTS AND CHILDREN AGES 6 YEARS AND OLDER.
Regulatory Exclusivity Expiration:Feb 14, 2023
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Regulatory Exclusivity Expiration:Jun 22, 2021
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY

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